PVV Satyanaryana et al., IJSID, 2012, 2 (1), International Journal of Science Innovations and Discoveries

Size: px
Start display at page:

Download "PVV Satyanaryana et al., IJSID, 2012, 2 (1), 226-231. International Journal of Science Innovations and Discoveries"

Transcription

1 ISSN: IJSID International Journal of Science Innovations and Discoveries An International peer Review Journal for Science Research Article Available online through RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYISIS OF RIVAROXABAN IN PHARMACEUTICAL DOSAGE FORMS P.V.V Satyanarayana* and Alavala Siva Madhavi Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India Received: Accepted: *Corresponding Author Address: Name: PVV. Satyanaryana Place: Guntur, AP, India ABSTRACT A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for assay of Rivaroxabanin tablet dosage form. Isocratic elution at a flow rate of 1ml min -1 was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of THF:MEOH:ACN 10:40:50 (v/v/v). The UV detection wavelength was at 270 nm. Linearity was observed in concentration range of ppm. The retention time for Rivaroxabanwas 2.55 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Rivaroxabanin pharmaceutical dosage forms. INTRODUCTION Keywords: Rivaroxaban, HPLC, Linearity, Precision, Recovery, 270nm INTRODUCTION 226

2 INTRODUCTION Rivaroxaban is an oral anticoagulant invented and manufactured by Bayer; in a number of countries it is marketed as Xarelto. [1] In the United States, it is marketed by Janssen Pharmaceutica. [2] It is the first available orally active direct factor Xa inhibitor. Rivaroxaban is well absorbed from the gut and maximum inhibition of factor Xa occurs four hours after a dose. The effects lasts 8 12 hours, but factor Xa activity does not return to normal within 24 hours so once-daily dosing is possible. Rivaroxaban is an oxazolidinone derivative optimized for inhibiting both free Factor Xa and Factor Xa bound in the prothrombinase complex. [5] It is a highly selective direct Factor Xa inhibitor with oral bioavailability and rapid onset of action. Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated Factor II), and no effects on platelets have been demonstrated. [1] Rivaroxaban has predictable pharmacokinetics across a wide spectrum of patients (age, gender, weight, race) and has a flat dose response across an eightfold dose range (5 40 mg). [6] Clinical trial data have shown that it allows predictable anticoagulation with no need for dose adjustments and routine coagulation monitoring. [1] However, these trials have excluded patients with liver disease and end-stage liver disease; therefore, the safety of rivaroxaban in these populations is unknown. Rivaroxaban bears a striking structural similarity to the antibiotic linezolid: both drugs share the same oxazolidinone-derived core structure. Accordingly, rivaroxaban was studied for any possible antimicrobial effects and for the possibility of mitochondrial toxicity, which is a known complication of long-term linezolid use. Studies found that neither rivaroxaban nor its metabolites have any antibiotic effect against Gram-positive bacteria. As for mitochondrial toxicity, in vitro studies found the risk to be low, and not likely to be of clinical consequence because rivaroxaban is only meant (and approved) for shortterm use. [6] Figure.1 Structure Of Rivaroxaban EXPERIMENTAL Chemicals and reagents All HPLC SOLVENTS used like Acetonitrile,Water Methanol,Orthophosphoric Acid which are of HPLC grade were purchased from E.Merck, Instrumentation and analytical conditions: The analysis of the drug was carried out on Shimadzu HPLC model (VP series) containing LC-10AT (VP series) pump, variable wave length programmable UV/visible detector SPD-10AVP and rheodyne injector (7725i) with 20µl fixed loop. Chromatographic analysis was performed using Inertsil ODS C-18 column with 250 x 4.6mm internal diameter and 5µm particle size. Shimadzu electronic balance (AX-200) was used for weighing. Isocratic elution with THF: Methanol,Acetonitrile 10:40:50 (v/v/v) was selected with a flow rate of 1.0 ml min -1.The detection wavelength was set at 270nm with a runtime of 6 min. The mobile phase was prepared freshly and it was degassed by sonicating for 5 min before use. The column was equilibrated for at 227

3 least 30min with the mobile phase flowing through the system. The column and the HPLC system were kept at ambient temperature. Preparation of Stock, working standard solutions and Sample solutions : 100mg of Rivaroxabanwas weighed and transferred (working standard) into a 100ml volumetric flask. The diluent methanol was added and sonicated to dissolve it completely and made up to the mark with the same solvent. Further the prepared solution filtered through Ultipor N 66 Nylon 6, 6 membrane sample filter paper. The calibration curve was plotted with the concentrations of the ppm working standard solutions. Calibration solutions were prepared and analyzed immediately after preparation. Method Validation procedure The objective of the method validation is to demonstrate that the method is suitable for its intended purpose as it is stated in ICH guidelines. The method was validated for linearity, precision, accuracy, specificity, and limit of detection, limit of quantification, robustness and system suitability. Linearity The developed method has been validated as per ICH guidelines (Zucman D, 2007). Working standard solutions of Rivaroxabanin the mass concentration range of 1mg/ml to 0.2 mg/ml was injected into the chromatographic system. The chromatograms were developed and the peak area was determined for each concentration of the drug solution. Calibration curve of Rivaroxabanwas obtained by plotting the peak area ratio versus the applied concentrations of Axitinib. The linear correlation coefficient was found to be Table 1: Linearity of Rivaroxaban S.NO CONC ppm AREA Figure 2: Calibration curve of Rivaroxaban 228

4 Precision PVV Satyanaryana et al., IJSID, 2012, 2 (1), Table.2: Linear Regression Data for Calibration curve Drug Axitinib Concentration range ppm Slope (m) Intercept (b) Correlation coefficient % RSD Repeatability of the method was checked by injecting replicate injections of 70 ppm of the solution for six times on the same day as intraday precision study of Rivaroxabanand the RSD was found to be Accuracy INJECTION INTERDAY INTRADAY S.D = R.S.D =0.056 S.D = R.S.D =0.066 Table 3: Precision parameters of Rivaroxaban The accuracy of the method was determined by calculating recovery of Rivaroxaban(50,75,100ppm) by the method of standard addition. Known amount of Rivaroxaban was added to a pre quantified sample solution and the amount of Rivaroxabanwas estimated by measuring the peak area ratios and by fitting these values to the straight line equation of calibration curve. The recovery studies were carried out three times over the specified concentration range and amount of Rivaroxabanwas estimated by measuring the peak area ratios by fitting these values to the straight line equation of calibration curve. From the above determination, percentage recovery and standard deviation of percentage recovery were calculated. Figure 3: Typical chromatogram of Axitinib 229

5 Table 4: Accuracy results of Axitinib Recovey Conc. of sample ppm Recovery % of recovery % of Average recovery 50% % % SPECIFICITY The specificity of the method was determined by comparing test results obtained from analysis of sample solution containing excipients with that of test results those obtained from standard drug. LOD and LOQ Limit of detection (LOD) and limit of quantification (LOQ) were calculated as 2 microgram/ml and 6 microliter respectively as per ICH guide-lines. Robustness varied. Ruggedness To determine the robustness of the method, two parameters from the optimized chromatographic conditions were Inter day variations were performed by using six replicate injections of standard and sample solutions of concentrations which were prepared and analyzed by different analyst on three different days over a period of one week. Ruggedness also expressed in terms of percentage relative standard deviation. Table 5: Ruggedness Results. Parameter Modification Peak Area % of change M.PHASE THF10%:MeOH 60%:ACN30% PH WAVELENGTH 272 nm System Suitability Parameter: System suitability tests were carried out on freshly prepared standard stock solutions of Rivaroxaban and it was calculated by determining the standard deviation of Rivaroxaban standards by injecting standards in six replicates at 6 minutes interval and the values were recorded. Table 5: System suitability parameters of Axitinib Parameters Values λ max (nm) 270 nm Beer s law limit (μg/ml) ppm Correlation coefficient Retention time 2.55 min Theoretical plates Tailing factor 1.8 Limit of detection 2 ppm Limit of quantification 6 ppm 230

6 RESULT AND DISCUSSION Optimization of the chromatographic conditions The nature of the sample, its molecular weight and solubility decides the proper selection of the stationary phase. The drug Rivaroxabanbeing non-polar is preferably analyzed by reverse phase columns and accordingly C18 column was selected. So the elution of the compound from the column was influenced by polar mobile phase. The concentration of the methanol and Acetonitrile were optimized to give symmetric peak with short run time based on asymmetric factor and peak area obtained. Different mobile phases were tried but satisfactory separation, well resolved and good symmetrical peaks were obtained with the mobile phase Methanol,ACN,THF 40:50:10 (V/V/V). The retention time of Rivaroxabanwas found to be 2.55 min, which indicates a good base line. The RSD values for accuracy and precision studies obtained were less than 2% which revealed that developed method was accurate and precise. The system suitability and validation parameters are given in Table 4. The high percentage of recovery of Rivaroxabanwas found to be indicating that the proposed method is highly accurate. Proposed liquid chromatographic method was applied for the determination of Rivaroxabanin tablet formulation. The result for Rivaroxabanwas comparable with a corresponding labelled amount (Table 6). The absence of additional peaks indicates no interference of the excipients used in the tablets. Formulation Tablet dosage Sample concentration Amount of drug estimated XARELTO 10mg Table 6: Tablet estimation of Axitinib CONCLUSION A validated RP-HPLC method has been developed for the determination of Rivaroxabanin tablet dosage form. The proposed method is simple, rapid, accurate, precise and specific. Its chromatographic run time of 8 min allows the analysis of a large number of samples in short period of time. Therefore, it is suitable for the routine analysis of Rivaroxabanin pharmaceutical dosage form. REFERENCES 1. "Xarelto: Summary of Product Characteristics". Bayer Schering Pharma AG "FDA Approves XARELTO (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery". Janssen Pharmaceutica. 3. "Bayer's Xarelto Approved in Canada" (Press release). Bayer. 4. "Bayer s Novel Anticoagulant Xarelto now also Approved in the EU". Bayer. 5. Roehrig S, Straub A, Pohlmann J, et al. (September 2005). "Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)- 2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY ): an oral, direct factor Xa inhibitor". Journal of Medicinal Chemistry 48 (19): European Medicines Agency (2008). "CHP Assessment Report for Xarelto 7. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein DVT Dose-Ranging Study, Harry R. Buller, Blood September 15, 2008 vol. 112 no Interpretation of Benefit-Risk of Enoxaparin as Comparator in the RECORD Program: Rivaroxaban Oral Tablets (10 milligrams) for Use in Prophylaxis in Deep Vein Thrombosis and Pulmonary Embolism in Patients Undergoing Hip or Knee Replacement Surgery, David Van Thiel, CLIN APPL THROMB HEMOSTAugust 2009 vol. 15 no

International Journal of Research and Reviews in Pharmacy and Applied science. www.ijrrpas.com

International Journal of Research and Reviews in Pharmacy and Applied science. www.ijrrpas.com International Journal of Research and Reviews in Pharmacy and Applied science www.ijrrpas.com P.V.V.Satyanarayana*, Alavala Siva Madhavi NEW SPECTROPHOTOMETRIC METHODS FOR THE QUANTITATIVE ESTIMATION OF

More information

Development of validated RP- HPLC method for estimation of rivaroxaban in pharmaceutical formulation

Development of validated RP- HPLC method for estimation of rivaroxaban in pharmaceutical formulation IJPAR Vol.4 Issue 4 Oct Dec - 2015 Journal Home page: ISSN: 2320-2831 Research Article Open Access Development of validated RP- HPLC method for estimation of rivaroxaban in pharmaceutical formulation V.

More information

A VALIDATED RP-HPLC METHOD FOR ESTIMATION OF REGORAFENIB IN BULK AND TABLET DOSAGE FORM

A VALIDATED RP-HPLC METHOD FOR ESTIMATION OF REGORAFENIB IN BULK AND TABLET DOSAGE FORM A VALIDATED RP-HPLC METHOD FOR ESTIMATION OF REGORAFENIB IN BULK AND TABLET DOSAGE FORM ABSTRACT A simple, selective, linear and accurate isocratic RP-HPLC method has been developed for the estimation

More information

Photolytic-Thermal Degradation Study And Method Development Of Rivaroxaban By RP-HPLC

Photolytic-Thermal Degradation Study And Method Development Of Rivaroxaban By RP-HPLC International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.5, No.3, pp 1254-1263, July-Sept 2013 Photolytic-Thermal Degradation Study And Method Development Of Rivaroxaban By

More information

A NEW METHOD DEVELOPMENT AND VALIDATION FOR ANALYSIS OF RIVAROXABAN IN FORMULATION BY RP HPLC

A NEW METHOD DEVELOPMENT AND VALIDATION FOR ANALYSIS OF RIVAROXABAN IN FORMULATION BY RP HPLC A NEW METHOD DEVELOPMENT AND VALIDATION FOR ANALYSIS OF RIVAROXABAN IN FORMULATION BY RP HPLC K.Chandra sekhar, P. Satya vani, A. Dhana lakshmi, Ch.LL.Devi, Anupama Barik, Narendra Devanaboyina * Department

More information

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF BENFOTIAMINE IN BULK AND DOSAGE FORM

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF BENFOTIAMINE IN BULK AND DOSAGE FORM INTERNATIONAL JOURNAL OF PHARMACEUTICAL, CHEMICAL AND BIOLOGICAL SCIENCES Available online at www.ijpcbs.com Research Article DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF BENFOTIAMINE

More information

+++#,# & %!"#$%& '"#()*

+++#,# & %!#$%& '#()* +++#,#! "#$#%&"##$!'#&("&!"# $ %& %& & %!"#$%& '"#()* +++#,# Research Article Chemistry International Journal of Pharma and Bio Sciences ISSN 0975-6299 A NOVEL RP-HPLC METHOD FOR THE QUANTIFICATION OF

More information

Reversed Phase High Presssure Liquid Chromatograhphic Technique for Determination of Sodium Alginate from Oral Suspension

Reversed Phase High Presssure Liquid Chromatograhphic Technique for Determination of Sodium Alginate from Oral Suspension International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.2, No.2, pp 1634-1638, April-June 2010 Reversed Phase High Presssure Liquid Chromatograhphic Technique for Determination

More information

[Research article] RP-HPLC Assay Method Validation for the estimation of new Antiretroviral drug Lamivudine in Bulk and Tablet dosage form

[Research article] RP-HPLC Assay Method Validation for the estimation of new Antiretroviral drug Lamivudine in Bulk and Tablet dosage form 12 IJPAR Volume 1 Issue 1 Dec_ 2012 Available Online at: www.ijpar.com [Research article] RP-HPLC Assay Method Validation for the estimation of new Antiretroviral drug in Bulk and Tablet dosage form *

More information

Research Article. Stress study and estimation of a potent anticoagulant drug rivaroxaban by a validated HPLC method: Technology transfer to UPLC

Research Article. Stress study and estimation of a potent anticoagulant drug rivaroxaban by a validated HPLC method: Technology transfer to UPLC Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2015, 7(10):65-74 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Stress study and estimation of a potent anticoagulant

More information

Pelagia Research Library. Development of validated RP-HPLC method for determination of letrozole in bulk and its pharmaceutical dosage forms

Pelagia Research Library. Development of validated RP-HPLC method for determination of letrozole in bulk and its pharmaceutical dosage forms Available online at www.pelagiaresearchlibrary.com Der Pharmacia Sinica, 2011, 2 (2):263-269 ISSN: 0976-8688 CODEN (USA): PSHIBD Development of validated RP-HPLC method for determination of letrozole in

More information

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE Rajgor VM,, 2014; Volume 3(3): 188-197 INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE ANALYTICAL METHOD DEVELOPEMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF MEMANTINE HCL AND

More information

Journal of Chemical and Pharmaceutical Research

Journal of Chemical and Pharmaceutical Research Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(3):363-374 Development and validation of RP-HPLC method

More information

Method development and validation of RP-HPLC method for estimation of imatinib mesylate in pure and pharmaceutical dosage form

Method development and validation of RP-HPLC method for estimation of imatinib mesylate in pure and pharmaceutical dosage form Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2015, 7 (3):33-38 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR DETERMINATION OF DRONEDARONE IN BULK AND PHARMACEUTICAL FORMULATION

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR DETERMINATION OF DRONEDARONE IN BULK AND PHARMACEUTICAL FORMULATION Page179 Research Article Pharmaceutical Sciences ABSTRACT DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR DETERMINATION OF DRONEDARONE IN BULK AND PHARMACEUTICAL FORMULATION Kishore Konam 1 & Dharmeshwar

More information

Palled Mahesh 1 Karagane Swapnalee 1,Mane Aruna 1,, Bhat Anilchandra 1,Shinde Prashanti 1 CH 3 .HCI

Palled Mahesh 1 Karagane Swapnalee 1,Mane Aruna 1,, Bhat Anilchandra 1,Shinde Prashanti 1 CH 3 .HCI International Journal of Pharmaceutical Science Invention ISSN (Online): 2319 6718, ISSN (Print): 2319 670X Volume 2 Issue 2 February 2013 PP.09-15 Analytical Method Development And Validation Of Acetaminophen,

More information

Development and Validation of HPLC Method for the Quantification of Anticancer Peptide

Development and Validation of HPLC Method for the Quantification of Anticancer Peptide http://www.e-journals.in Chemical Science Transactions DOI:10.7598/cst2014.809 2014, 3(3), 1078-1082 RESEARCH ARTICLE Development and Validation of HPLC Method for the Quantification of Anticancer Peptide

More information

Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form

Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form ISSN- 2231 5667 (Print) www.asianpharmaonline.org ISSN- 2231 5675 (Online) 0974-3618 RESEARCH ARTICLE Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical

More information

Analytical Method Validation for Assay, Related substances & Dissolution. N A Y A N K S H A T R I 1 8 / 0 1 /

Analytical Method Validation for Assay, Related substances & Dissolution. N A Y A N K S H A T R I 1 8 / 0 1 / Analytical Method Validation for Assay, Related substances & Dissolution. N A Y A N K S H A T R I 1 8 / 0 1 / 2 0 1 3 Definitions The objective of validation of an analytical procedure is to demonstrate

More information

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry BY GHULAM A. SHABIR Introduction Methods Validation: Establishing documented evidence that provides a high

More information

RP- HPLC Method for Simultaneous Estimation of Paracetamol and Etoricoxib from Bulk and Tablets

RP- HPLC Method for Simultaneous Estimation of Paracetamol and Etoricoxib from Bulk and Tablets RP- HPLC Method for Simultaneous Estimation of Paracetamol and Etoricoxib from Bulk and Tablets S. R. Pattan *1, S. G. Jamdar 2, R. K. Godge 1, N. S. Dighe 1, A.V. Daithankar 1, S. A. Nirmal 1, M.G.Pai

More information

International Journal of Pharmaceutical and Life Sciences. Volume 1, Issue 1, Serial 2: August 2012

International Journal of Pharmaceutical and Life Sciences. Volume 1, Issue 1, Serial 2: August 2012 DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF VILDAGLIPTIN FROM TABLET DOSAGE FORM Aparajita Malakar*, Bishwajit Bokshi, Dilruba Nasrin Pharmacy Discipline, Life Science School, Khulna

More information

Research Article DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE ESTIMATION OF GLIPIZIDE IN PHARMACEUTICAL DOSAGE FORM

Research Article DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE ESTIMATION OF GLIPIZIDE IN PHARMACEUTICAL DOSAGE FORM WWW.IJAPBR.COM International journal of Applied Pharmaceutical and Biological Research, 2016; 1(2):87-91 Research Article ISSN : 2456-0189 DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE ESTIMATION OF

More information

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Benfotiamine and Metformin hydrochloride in Tablet Dosage Form

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Benfotiamine and Metformin hydrochloride in Tablet Dosage Form Original Ar cle Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Benfotiamine and Metformin hydrochloride in Tablet Dosage Form B. Pavan Adithya, M. Vijayalakshmi and J.Mahesh

More information

High Performance Thin Layer Chromatographic Method for Estimation of Cefprozil in Tablet Dosage Form

High Performance Thin Layer Chromatographic Method for Estimation of Cefprozil in Tablet Dosage Form ISSN: 0973-4945; CODEN ECJHAO E- Chemistry http://www.e-journals.net Vol. 5, No.3, pp. 427-430, July 2008 High Performance Thin Layer Chromatographic Method for Estimation of Cefprozil in Tablet Dosage

More information

SIMULTANEOUS DETERMINATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

SIMULTANEOUS DETERMINATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY CHAPTER 5 SIMULTANEOUS DETERMINATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY CHAPTER 5 Simultaneous determination of Telmisartan

More information

Development of validated RP-HPLC method for the simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form

Development of validated RP-HPLC method for the simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form International Journal of Advances in Pharmaceutics ISSN: 2320 4923; DOI: 10.7439/ijap Volume 3 Issue 1 [2014] Journal home page:http://ijap.ssjournals.com Research Article Development of validated RP-HPLC

More information

A Practical Approach to Validation of HPLC Methods Under Current Good Manufacturing Practices

A Practical Approach to Validation of HPLC Methods Under Current Good Manufacturing Practices A Practical Approach to Validation of HPLC Methods Under Current Good Manufacturing Practices Introduction Analytical methods validation is an important regulatory requirement in pharmaceutical analysis.

More information

Quantitative work in HPLC

Quantitative work in HPLC Quantitative work in HPLC Dr. Shulamit Levin Medtechnica www.forumsci.co.il/hplc Dr. Shulamit Levin, Medtechnica 1 Quantitative work in HPLC Dr. Shulamit Levin Medtechnica Data Handling Analytical Chemistry

More information

USP Method Transfer of Donepezil Tablets from HPLC to UPLC

USP Method Transfer of Donepezil Tablets from HPLC to UPLC USP Method Transfer of Donepezil Tablets from HPLC to UPLC Mia Summers and Kenneth J. Fountain Waters Corporation, 34 Maple St., Milford, MA, USA APPLICATION BENEFITS Updating USP Methods from HPLC to

More information

High performance thin layer chromatographic method for estimation of deflazacort in tablet

High performance thin layer chromatographic method for estimation of deflazacort in tablet ISSN: 2231-3354 Received on: 07-09-2011 Revised on: 11-09-2011 Accepted on: 13-09-2011 High performance thin layer chromatographic method for estimation of deflazacort in tablet Patel Satish A and Patel

More information

Development and validation of RP-HPLC method for the simultaneous determination of Adapalene-Benzoyl Peroxide combination gel

Development and validation of RP-HPLC method for the simultaneous determination of Adapalene-Benzoyl Peroxide combination gel Scholars www.setscholars.org Knowledge is Power October 2012 Volume 1, Issue 5 Article #01 IJASETR Research Paper ISSN: 1839-7239 Development and validation of RP-HPLC method for the simultaneous determination

More information

ANALYTICAL METHODS INTERNATIONAL QUALITY SYSTEMS

ANALYTICAL METHODS INTERNATIONAL QUALITY SYSTEMS VALIDATION OF ANALYTICAL METHODS 1 GERT BEUVING INTERNATIONAL PHARMACEUTICAL OPERATIONS TASKS: - Internal auditing - Auditing of suppliers and contract manufacturers - Preparing for and guiding of external

More information

Determination of Acrylamide in Food Simulants

Determination of Acrylamide in Food Simulants Determination of Acrylamide in Food Simulants WARNING: Acrylamide monomer is toxic and readily absorbed through the skin. The monomer should be handled in a fume cupboard using gloves. 1 SCOPE This method

More information

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BENFOTIAMINE: REVIEW

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BENFOTIAMINE: REVIEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BENFOTIAMINE: REVIEW NANJESHGOWDA *, JOSE GNANA BABU C and TAMIZH MANI T. *Department of Pharmaceutical Analysis, Bharathi College of Pharmacy, Bharathi

More information

Journal of Chemical and Pharmaceutical Research

Journal of Chemical and Pharmaceutical Research Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2010, 2(6):62-67 Development and validation of RP- HPLC method

More information

Available online at Current Pharma Research 3 (4), 2013, Original Article

Available online at  Current Pharma Research 3 (4), 2013, Original Article Available online at www.cpronline.in Current Pharma Research 3 (4), 2013, 994 998. Original Article Development and Validation of HPLC Method for Simultaneous Estimation of Amoxycillin Trihydrate and Potassium

More information

HPLC Analysis of Acetaminophen Tablets with Waters Alliance and Agilent Supplies

HPLC Analysis of Acetaminophen Tablets with Waters Alliance and Agilent Supplies HPLC Analysis of Acetaminophen Tablets with Waters Alliance and Agilent Supplies Application Note Small Molecule Pharmaceuticals Authors Jignesh Shah, Tiantian Li, and Anil Sharma Agilent Technologies,

More information

International Journal of Pharma and Bio Sciences V1(2)2010

International Journal of Pharma and Bio Sciences V1(2)2010 1 Central Drugs Laboratory,Kolkata Angshuman Biswas 1 and Arindam Basu 1 *Corresponding author bangshuman@rediffmail.com ABSTRACT A fast and reliable high performance liquid chromatography method for determination

More information

Analytical Method Validation

Analytical Method Validation Analytical Method Validation A. Es-haghi Ph.D. Dept. of Physico chemistry vaccine and serum research institute a.eshaghi@rvsri.ir http://www.rvsri.ir/ Introduction Test procedures for assessment of the

More information

Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations

Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations Research In Pharmaceutical Biotechnology Vol. 2(1), pp. 001-006, February, 2010 Available online at http://www.academicjournals.org/rpb 2010 Academic Journals Full Length Research Paper Validation and

More information

By T.Sudha, T.Raghupathi

By T.Sudha, T.Raghupathi Global Journal of Medical research Volume 11 Issue 2 Version 1.0 Type: Double Blind Peer Reviewed International Research Journal Publisher: Global Journals Inc. (USA) Online ISSN: 0975-5888 Reverse Phase

More information

Quantitative & Qualitative HPLC

Quantitative & Qualitative HPLC Quantitative & Qualitative HPLC i Wherever you see this symbol, it is important to access the on-line course as there is interactive material that cannot be fully shown in this reference manual. Contents

More information

About the RECORD Clinical Trial Program

About the RECORD Clinical Trial Program About the RECORD Clinical Trial Program Fast facts RECORD was a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism

More information

DEVELOPMENT AND VALIDATION OF HPLC ANALYTICAL ASSAY METHOD FOR MEFENAMIC ACID TABLET (PONSTAN)

DEVELOPMENT AND VALIDATION OF HPLC ANALYTICAL ASSAY METHOD FOR MEFENAMIC ACID TABLET (PONSTAN) Int. J. Chem. Sci.: 12(1), 2014, 62-72 ISSN 0972-768X www.sadgurupublications.com DEVELOPMENT AND VALIDATION OF HPLC ANALYTICAL ASSAY METHOD FOR MEFENAMIC ACID TABLET (PONSTAN) FOUAD FADHIL AL-QAIM a,b,

More information

Int. J. Pharm. Sci. Rev. Res., 28(2), September October 2014; Article No. 14, Pages: 64-68

Int. J. Pharm. Sci. Rev. Res., 28(2), September October 2014; Article No. 14, Pages: 64-68 Research Article Development and Validation of RP-HPLC Method for the Simultaneous Determination of and in Oral Suspension Dosage Form Tuani YT* 1, Kissi FA 2, Sackey J 1,3, Gordon AJ 4, Akanji O 5 1 Letap

More information

Development and Validation of a RP-HPLC Method for the Quantification of Omeprazole in Pharmaceutical Dosage Form

Development and Validation of a RP-HPLC Method for the Quantification of Omeprazole in Pharmaceutical Dosage Form Available Online Publications J. Sci. Res. 5 (2), 335-342 (2013) JOURNAL OF SCIENTIFIC RESEARCH www.banglajol.info/index.php/jsr Development and Validation of a RP-HPLC Method for the Quantification of

More information

Simultaneous determination of L-ascorbic acid and D-iso-ascorbic acid (erythorbic acid) in wine by HPLC and UV-detection (Resolution Oeno 11/2008)

Simultaneous determination of L-ascorbic acid and D-iso-ascorbic acid (erythorbic acid) in wine by HPLC and UV-detection (Resolution Oeno 11/2008) Method OIV-MA-AS313-22 Type II method Simultaneous determination of L-ascorbic acid and D-iso-ascorbic acid (erythorbic acid) in wine by HPLC and UV-detection (Resolution Oeno 11/2008) 1. Introduction

More information

A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ORLISTAT IN BULK AND PHARMACEUTICAL DOSAGE FORMS

A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ORLISTAT IN BULK AND PHARMACEUTICAL DOSAGE FORMS A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ORLISTAT IN BULK AND PHARMACEUTICAL DOSAGE FORMS Sreekanth Nama, 1, *, Babu Rao Chandu 2, Mukkanti Khagga 3 1, *Department of Pharmacy, College of Public

More information

ANALYSIS OF FOOD AND NATURAL PRODUCTS LABORATORY EXERCISE

ANALYSIS OF FOOD AND NATURAL PRODUCTS LABORATORY EXERCISE ANALYSIS OF FOOD AND NATURAL PRODUCTS LABORATORY EXERCISE Determination of vitamins, caffeine and preservatives (method: liquid chromatography with UV detection) Exercise guarantor: Assoc.Prof. Ing.Věra

More information

Scholars Research Library. A validated RP-HPLC method for estimation of Rivastigmine in pharmaceutical formulations

Scholars Research Library. A validated RP-HPLC method for estimation of Rivastigmine in pharmaceutical formulations Available online at www.scholarsresearchlibrary.com Der Pharmacia Lettre, 2011, 3(3):421-426 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4 A validated RP-HPLC method

More information

Session 3 Topics. Argatroban. Argatroban. Drug Use and Adverse Effects. Laboratory Monitoring of Anticoagulant Therapy

Session 3 Topics. Argatroban. Argatroban. Drug Use and Adverse Effects. Laboratory Monitoring of Anticoagulant Therapy ~~Marshfield Labs Presents~~ Laboratory Monitoring of Anticoagulant Therapy Session 3 of 4 Michael J. Sanfelippo, M.S. Technical Director, Coagulation Services Session 3 Topics Direct Thrombin Inhibitors:

More information

HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF TADALAFIL IN TABLET DOSAGE FORM

HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF TADALAFIL IN TABLET DOSAGE FORM Volume 1, Issue 3, 2011. ISSN: 2249-3387 Journal home page: http://www.ajptr.com/ HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF TADALAFIL IN TABLET DOSAGE FORM Satish A. Patel

More information

MCHENRY WESTERN LAKE COUNTY EMS SYSTEM OPTIONAL CE ADVANCED LEVEL (EMTP, PHRN, ECRN) August 2013. Anticoagulants

MCHENRY WESTERN LAKE COUNTY EMS SYSTEM OPTIONAL CE ADVANCED LEVEL (EMTP, PHRN, ECRN) August 2013. Anticoagulants MCHENRY WESTERN LAKE COUNTY EMS SYSTEM OPTIONAL CE ADVANCED LEVEL (EMTP, PHRN, ECRN) August 2013 Anticoagulants Anticoagulants are agents that prevent the formation of blood clots. Before we can talk about

More information

Analytical Specifications RIVAROXABAN

Analytical Specifications RIVAROXABAN Page 1 of 9 ANALYTE NAME AND STRUCTURE - RIVAROXABAN SYNONYMS Xarelto CATEGORY Anticoagulant TEST CODE PURPOSE Therapeutic Drug Monitoring GENERAL RELEVANCY BACKGROUND Xarelto (rivaroxaban) is an orally

More information

VALIDATED RP-HPLC METHOD FOR FLUVASTATIN SODIUM IN BULK AND ITS DOSAGE FORM

VALIDATED RP-HPLC METHOD FOR FLUVASTATIN SODIUM IN BULK AND ITS DOSAGE FORM Journal of Pharmaceutical Sciences and Research www.jpsr.pharmainfo.in VALIDATED RP-HPLC METHOD FOR FLUVASTATIN SODIUM IN BULK AND ITS DOSAGE FORM J.Saminathan.* 1,A.S.K.Sankar 1,K.Anandakumar 1,S.Srinivasan.

More information

An HPLC Analysis of Sweeteners in Beverages

An HPLC Analysis of Sweeteners in Beverages CHEM 311L Quantitative Analysis Laboratory Version 1.1 An HPLC Analysis of Sweeteners in Beverages In this laboratory exercise we will perform a separation of the components of diet soft drinks using reversed-phase

More information

DETERMINING CAFFEINE CONCENTRATIONS IN SOFT DRINKS (Revised: )

DETERMINING CAFFEINE CONCENTRATIONS IN SOFT DRINKS (Revised: ) INTRODUCTION DETERMINING CAFFEINE CONCENTRATIONS IN SOFT DRINKS (Revised: 5-18-93) Chromatography is a separation technique that was first used by the Russian botanist Mikhal Tsvet. Around the turn of

More information

Method development and validation of HPLC method for determination of azithromycin

Method development and validation of HPLC method for determination of azithromycin Available online at www.derpharmachemica.com Scholars Research Library Der Pharma Chemica, 2013, 5(4):166-172 (http://derpharmachemica.com/archive.html) ISSN 0975-413X CODEN (USA): PCHHAX Method development

More information

9040 S. Rita Road, Suite 1100 Tucson, Arizona T: (520) F: (520)

9040 S. Rita Road, Suite 1100 Tucson, Arizona T: (520) F: (520) ANALYTICAL REPORT DETERMINATION OF CHOLECALCIFEROL (VITAMIN D 3 ) IN XXXXXXXXX 1. Samples: The samples were received on xxxxxxxx, 2009, for Vitamin D3 (cholecalciferol) determination. Sample ID XXXX XXXX

More information

TECHNICAL CHLORPYRIFOS

TECHNICAL CHLORPYRIFOS TECHNICAL WHO/SIT/21.R3 TECHNICAL CHLORPYRIFOS Full specification WHO/SIT/21.R3 Revised 10 December 1999 1. Specification 1.1 Description The material shall consist of chlorpyrifos together with related

More information

Estimation and Stress Study of a Potent Anticoagulant Drug Rivaroxaban by a Validated HPLC Method

Estimation and Stress Study of a Potent Anticoagulant Drug Rivaroxaban by a Validated HPLC Method 2 ESTIMATION AND STRESS STUDY OF A POTENT ANTICOAGULANT DRUG RIVAROXABAN BY A VALIDATED HPLC METHOD II Estimation and Stress Study of a Potent Anticoagulant Drug Rivaroxaban by a Validated HPLC Method

More information

SIMULTANEOUS DETERMINATION OF NALTREXONE AND 6- -NALTREXOL IN SERUM BY HPLC

SIMULTANEOUS DETERMINATION OF NALTREXONE AND 6- -NALTREXOL IN SERUM BY HPLC SIMULTANEOUS DETERMINATION OF NALTREXONE AND 6- -NALTREXOL IN SERUM BY HPLC Katja SÄRKKÄ, Kari ARINIEMI, Pirjo LILLSUNDE Laboratory of Substance Abuse, National Public Health Institute Manerheimintie,

More information

INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES

INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES Validation of UV-Spectrophotometric and RP-HPLC methods for the simultaneous analysis of Paracetamol and Aceclofenac in marketed tablets S.M. Ashraful

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Q2B Validation of Analytical Procedures: Methodology November 1996 ICH Guidance for Industry Q2B Validation of Analytical Procedures: Methodology Additional copies are available from:

More information

SUCRALOSE. White to off-white, practically odourless crystalline powder

SUCRALOSE. White to off-white, practically odourless crystalline powder SUCRALOSE Prepared at the 41st JECFA (1993), published in FNP 52 Add 2 (1993). Metals and arsenic specifications revised at the 63rd JECFA (2004). An ADI of 0-15 mg/kg bw was established at the 37th JECFA

More information

Develop a Quantitative Analytical Method for low (» 1 ppm) levels of Sulfate

Develop a Quantitative Analytical Method for low (» 1 ppm) levels of Sulfate Cantaurus, Vol. 7, 5-8, May 1999 McPherson College Division of Science and Technology Develop a Quantitative Analytical Method for low (» 1 ppm) levels of Sulfate Janet Bowen ABSTRACT Sulfate is used in

More information

Determination of Caffeine in Beverages HPLC-1

Determination of Caffeine in Beverages HPLC-1 Determination of in s HPLC-1 Introduction This experiment provides an introduction to the application of High Performance Liquid Chromatography (HPLC) to the solution of complex analytical problems. Cola

More information

Analysis of Riboflavin in a Vitamin Pill by Fluorescence Spectroscopy**

Analysis of Riboflavin in a Vitamin Pill by Fluorescence Spectroscopy** Analysis of Riboflavin in a Vitamin Pill by Fluorescence Spectroscopy** Objectives In this lab, you will use fluorescence spectroscopy to determine the mass and percentage of riboflavin in a vitamin pill.

More information

Transfer of a USP method for prednisolone from normal phase HPLC to SFC using the Agilent 1260 Infinity Hybrid SFC/UHPLC System Saving time and costs

Transfer of a USP method for prednisolone from normal phase HPLC to SFC using the Agilent 1260 Infinity Hybrid SFC/UHPLC System Saving time and costs Agilent Application Solution Transfer of a USP method for prednisolone from normal phase PLC to SFC using the Agilent 126 Infinity ybrid SFC/UPLC System Saving time and costs Application Note Pharmaceutical

More information

ANALYTICAL METHOD VALIDATION AND CLEANING VERIFICATION OF FELODIPINE BY HPLC METHOD

ANALYTICAL METHOD VALIDATION AND CLEANING VERIFICATION OF FELODIPINE BY HPLC METHOD ANALYTICAL METHOD VALIDATION AND CLEANING VERIFICATION OF FELODIPINE BY HPLC METHOD V.P. Pandey, Soma Sekhar, K. and K.R.P. Shenoy * Department of Pharmacy, Annamalai University, Annamalainagar 608002

More information

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors News Release For use outside the US and UK only Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com Bayer s Xarelto Approved in the EU for the Prevention of Stroke in Patients

More information

Validated HPLC Method for Simultaneous Quantitation of Diclofenac Sodium and Misoprostol in Bulk Drug and Formulation

Validated HPLC Method for Simultaneous Quantitation of Diclofenac Sodium and Misoprostol in Bulk Drug and Formulation Available online at www.pelagiaresearchlibrary.com Pelagia Research Library Der Chemica Sinica, 2010, 1 (2): 110-118 ISSN: 0976-8505 CODEN (USA) CSHIA5 Validated HPLC Method for Simultaneous Quantitation

More information

ABOUT XARELTO CLINICAL STUDIES

ABOUT XARELTO CLINICAL STUDIES ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the

More information

Research Article. Development and validation of a HPLC analytical assay method for dapoxetine tablets: A medicine for premature ejaculation

Research Article. Development and validation of a HPLC analytical assay method for dapoxetine tablets: A medicine for premature ejaculation Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2014, 6(7):1613-1618 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Development and validation of a HPLC analytical

More information

ANALYSIS OF FOOD AND NATURAL PRODUCTS LABORATORY EXERCISE

ANALYSIS OF FOOD AND NATURAL PRODUCTS LABORATORY EXERCISE ANALYSIS OF FOOD AND NATURAL PRODUCTS LABORATORY EXERCISE Determination of carbohydrates in foodstuff (LC/RID method) Exercise guarantor: Assoc. Prof. Karel Cejpek, Ph.D. CONTENT Required knowledge...

More information

HPLC method development and validation for simultaneous determination of lamivudine and tenofovir in tablet dosage

HPLC method development and validation for simultaneous determination of lamivudine and tenofovir in tablet dosage IJPAR Vol.4 Issue 3 July-Sep-2015 Journal Home page: ISSN: 2320-2831 Research article Open Access HPLC method development and validation for simultaneous determination of lamivudine and tenofovir in tablet

More information

Application Note. Determination of Nitrite and Nitrate in Fruit Juices by UV Detection. Summary. Introduction. Experimental Sample Preparation

Application Note. Determination of Nitrite and Nitrate in Fruit Juices by UV Detection. Summary. Introduction. Experimental Sample Preparation Application Note Determination of Nitrite and Nitrate in Fruit Juices by UV Detection Category Food Matrix Fruit Juice Method HPLC Keywords Ion pair chromatography, fruit juice, inorganic anions AZURA

More information

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1)

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY

More information

Development and validation of UV spectrophotometric method for the determination of rivaroxaban

Development and validation of UV spectrophotometric method for the determination of rivaroxaban Available online at www.derpharmachemica.com Scholars Research Library Der Pharma Chemica, 013, 5(4):1-5 (http://derpharmachemica.com/archive.html) ISSN 0975-413X CODEN (USA): PCHHAX Development and validation

More information

Analytical Test Report

Analytical Test Report Analytical Test Report Customer: Address (City, State): Purchase Order: Report Number: Project Number: Date Received: Date of Report: Test Location: Boulder, CO. Assay: Part Number: Amino Acids by HPLC

More information

Analytical Test Method Validation Report Template

Analytical Test Method Validation Report Template Analytical Test Method Validation Report Template 1. Purpose The purpose of this Validation Summary Report is to summarize the finding of the validation of test method Determination of, following Validation

More information

A practical and novel standard addition strategy to screen. pharmacodynamic components in traditional Chinese medicine using

A practical and novel standard addition strategy to screen. pharmacodynamic components in traditional Chinese medicine using Electronic Supplementary Material (ESI) for RSC Advances. This journal is The Royal Society of Chemistry 2015 A practical and novel standard addition strategy to screen pharmacodynamic components in traditional

More information

LIQUID CHROMATOGRAPHY HOW MUCH ASPIRIN, ACETAMINOPHEN, AND CAFFEINE ARE IN YOUR PAIN RELIEVER? USING HPLC TO QUANTITATE SUBSTANCES (Revised: 1-13-93)

LIQUID CHROMATOGRAPHY HOW MUCH ASPIRIN, ACETAMINOPHEN, AND CAFFEINE ARE IN YOUR PAIN RELIEVER? USING HPLC TO QUANTITATE SUBSTANCES (Revised: 1-13-93) INTRODUCTION HOW MUCH ASPIRIN, ACETAMINOPHEN, AND CAFFEINE ARE IN YOUR PAIN RELIEVER? USING HPLC TO QUANTITATE SUBSTANCES (Revised: 1-13-93) Headache, sore muscles, arthritis pain... How do you spell relief?

More information

Rao, et al., Int J Res Pharm Sci 2015, 5(2) ; 17 24. Available online at www.ijrpsonline.com. Research Article

Rao, et al., Int J Res Pharm Sci 2015, 5(2) ; 17 24. Available online at www.ijrpsonline.com. Research Article International Journal of Research in Pharmacy and Science Available online at www.ijrpsonline.com Research Article Stability-indicating UPLC method for determining related substances and degradants in

More information

VALIDATION OF HPLC METHOD FOR DETERMINATION OF DOCOSAHEXAENOIC ACID (DHA) IN MULIIVITAMIN CAPSULE DIAH WIDOWATI*, ROS SUMARNY, ESTI MUMPUNI

VALIDATION OF HPLC METHOD FOR DETERMINATION OF DOCOSAHEXAENOIC ACID (DHA) IN MULIIVITAMIN CAPSULE DIAH WIDOWATI*, ROS SUMARNY, ESTI MUMPUNI VALIDATION OF HPLC METHOD FOR DETERMINATION OF DOCOSAHEXAENOIC ACID (DHA) IN MULIIVITAMIN CAPSULE DIAH WIDOWATI*, ROS SUMARNY, ESTI MUMPUNI Fakultas Farmasi Universitas Pancasila Jln. Srengseng Sawah,

More information

Intelligent use of Relative Response Factors in Gas Chromatography-Flame Ionisation Detection

Intelligent use of Relative Response Factors in Gas Chromatography-Flame Ionisation Detection 52 May/June 2012 Intelligent use of Relative Response Factors in Gas Chromatography-Flame Ionisation Detection by Karen Rome and Allyson McIntyre, AstraZeneca, Macclesfield, SK10 2NA, UK Quantitative analysis

More information

Determination of Food Dye Concentrations in an Unknown Aqueous Sample Using HPLC

Determination of Food Dye Concentrations in an Unknown Aqueous Sample Using HPLC Determination of Food Dye Concentrations in an Unknown Aqueous Sample Using HPLC Abstract: High performance liquid chromatography (HPLC) was used to determine the identity and concentrations of food dyes

More information

Analysis of the Vitamin B Complex in Infant Formula Samples by LC-MS/MS

Analysis of the Vitamin B Complex in Infant Formula Samples by LC-MS/MS Analysis of the Vitamin B Complex in Infant Formula Samples by LC-MS/MS Stephen Lock 1 and Matthew Noestheden 2 1 AB SCIEX Warrington, Cheshire (UK), 2 AB SCIEX Concord, Ontario (Canada) Overview A rapid,

More information

International Journal of Medicine and Nanotechnology

International Journal of Medicine and Nanotechnology International Journal of Medicine and Nanotechnology Access online at www.medtechnano.com Original Article MEHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF RELATED COMPOUNDS IN DABIGATRAN ETEXILATE

More information

Randomized, double-blind, parallel-group, multicenter, doubledummy

Randomized, double-blind, parallel-group, multicenter, doubledummy ABOUT RECORD STUDIES FAST FACTS RECORD is a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism (VTE)

More information

Simultaneous determination of aspartame, benzoic acid, caffeine, and saccharin in sugar-free beverages using HPLC

Simultaneous determination of aspartame, benzoic acid, caffeine, and saccharin in sugar-free beverages using HPLC Simultaneous determination of aspartame, benzoic acid, caffeine, and saccharin in sugar-free beverages using HPLC Mackenzie Ree and Erik Stoa Department of Chemistry, Concordia College, 901 8 th St S,

More information

Determination of Aflatoxins in NeemAzal and NeemAzal-T/S

Determination of Aflatoxins in NeemAzal and NeemAzal-T/S Determination of Aflatoxins in NeemAzal and NeemAzal-T/S PLC-Method compiled by: Trifolio-M Gmb Sonnenstraße 22 35633 Lahnau, Germany Page 1 of 9 General Information about Aflatoxins Neem seed kernels

More information

Project 5: Scoville Heat Value of Foods HPLC Analysis of Capsaicinoids

Project 5: Scoville Heat Value of Foods HPLC Analysis of Capsaicinoids Willamette University Chemistry Department 2013 Project 5: HPLC Analysis of Capsaicinoids LABORATORY REPORT: Formal Writing Exercises PRE-LAB ASSIGNMENT Read the entire laboratory project and section 28C

More information

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR DETERMINATION OF CALCIUM OROTATE IN BULK AND TABLET DOSAGE FORM

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR DETERMINATION OF CALCIUM OROTATE IN BULK AND TABLET DOSAGE FORM ejpmr, 2016,3(5), 165-170 SJIF Impact Factor 3.628 Research Article EUROPEAN JOURNAL European OF PHARMACEUTICAL Journal of Pharmaceutical and Medical Research AND MEDICAL RESEARCH ISSN 2394-3211 www.ejpmr.com

More information

Licence for use in the UK is expected before the end of 2011

Licence for use in the UK is expected before the end of 2011 News Release FOR UK HEALTHCARE MEDIA ONLY Bayer HealthCare Bayer plc Bayer House Strawberry Hill Newbury Berkshire, RG14 1JA www.bayer.co.uk Bayer s Xarelto (rivaroxaban) Recommended by CHMP for EU Approval

More information

Development and Validation of Stability Indicating HPLC Method for Simultaneous Estimation of Amoxicillin and Clavulanic Acid in Injection

Development and Validation of Stability Indicating HPLC Method for Simultaneous Estimation of Amoxicillin and Clavulanic Acid in Injection American Journal of Analytical Chemistry, 2010, 1, 95-101 doi:10.4236/ajac.2010.13013 Published Online November 2010 (http://www.scirp.org/journal/ajac) Development and Validation of Stability Indicating

More information

Original article Method development and validation of paracetamol drug by RP-HPLC

Original article Method development and validation of paracetamol drug by RP-HPLC J M e d A l l i e d S c i 2 0 1 3 ; 3 ( 1 ) : 08-14 w w w. j m a s. i n P r i n t I S S N : 2 2 3 1 1 6 9 6 O n l i n e I S S N : 2 2 3 1 1 7 0 X Journal of Medical & Allied Sciences Original article Method

More information

Method Development and Validation of Sucralfate and Oxetacaine in Bulk Drug and Formulation by Rp-Hplc

Method Development and Validation of Sucralfate and Oxetacaine in Bulk Drug and Formulation by Rp-Hplc ISSN: 0976-4607 Research Article International Journal of Innovative Pharmaceutical Research Journal homepage: www.ijipr.com Method Development and Validation of Sucralfate and Oxetacaine in Bulk Drug

More information