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

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1 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 Department of Pharmaceutical Analysis & Quality Assurance, Bapatla College of Pharmacy, Bapatla , Andhra Pradesh, India ABSTRACT A new precise, reproducible and validated RP-HPLC method was developed for the simultaneous estimation of Benfotiamine and Metformin hydrochloride in tablet dosage form. The chromatographic conditions used for the separation was Phenomenex Luna C 18 (4.6x250mm, 5μ) with mobile phase comprised of acetonitrile: methanol: water: 0.1% OPA (40:20:35:5 %v/v). The flow rate was 1.0 ml/min with detection at 249 nm. The retention time of benfotiamine and metformin hydrochloride was found to be 3.84 and min respectively. The linearity was found to be in the range of 5 35 μg/ml for benfotiamine and for metformin hydrochloride μg/ml with correlation coefficients of and respectively. The proposed method is accurate with 99.1% % recovery for benfotiamine and 99.31% % recovery for metformin hydrochloride and precise (%RSD of repeatability, intra-day and inter-day variations were 0.33, , for benfotiamine and 0.28, , for metformin hydrochloride).the limit of detection (LOD) and limit of quantitation (LOQ) for benfotiamine 0.159, μg/ml and for metformin hydrochloride 0.949, 2.87 μg/ml respectively. The method can be used for the estimation of dosage form in routine analysis. Keywords: Benfotiamine, Metformin hydrochloride, RP-HPLC, Validation. INTRODUCTION Benfotiamine 1 (S-benzoylthiamine O-monophosphate) is a synthetic S-acyl derivative of thiamine (vitamin B 1 ) belonging to the family of compounds known as allithiamines. 2 It may ease pain from neuropathy, retinopathy, nephropathy. By blocking AGEs (advanced glycation end products), it prevent some complications due to diabetes, such as blood vessel damage and atherosclerosis (3). Metformin hydrochloride 1 (N,N-Dimethylimidodicarbonimidic diamide hydrochloride) is an oral antidiabetic drug in the biguanide class. It is the first-line drug of choice for the treatment of type 2 diabetes, in particular, in overweight and obese people and those with normal kidney function. 4 Combination of these two drugs is used in Infertility as it prevents the glycation of products which cause aging and thus helps in regularizing cycles and conception. The combination of these two drugs is not official in any pharmacopoeia; hence no official method is available for the simultaneous estimation of these two drugs in their combined dosage forms. The present communication describes simple, sensitive, accurate and precise RP-HPLC method for simultaneous estimation of both drugs in their combined tablet dosage forms. The validation of this method was carried out as per ICH guidelines. Received Date : Revised Date : Accepted Date : DOI: /rjps Address for correspondence B. Pavan Adithya Department of Pharmaceutical Analysis & Quality Assurance, Bapatla College of Pharmacy, Bapatla , Andhra Pradesh, India. Tel.: gmail.com RGUHS J Pharm Sci Vol 2 Issue 4 Oct Dec,

2 Reagents and materials The reference sample of metformin hydrochloride and benfotiamine were supplied by Elppe Chemicals Pvt. Ltd, Mumbai and Gulf exports, Mumbai respectively. The commercial fixed dose combination product was procured from the local market. HPLC grade methanol, acetonitrile, OPA were purchased from Merck specialities private ltd, Mumbai. Selection of mobile phase Based on sample solubility, stability and suitability various mobile phase compositions were tried to get a good resolution and sharp peaks. The standard solution containing mixture of two drugs, as well as individual drugs were run in various mobile phases containing different ratios of acetonitrile, methanol, water and OPA. The mobile phase containing acetonitrile: methanol: water: 0.1% OPA [40:20: 35: 5% v/v] proportion with detection wavelength 249 nm was selected, since it gave sharp resolved peaks with acceptable symmetry and significant retention times for both the drugs. Figure 1: Structure of Benfotiamine. Figure 2: Structure of Metformin hydrochloride. Literature survey reveals that few HPLC 5,6 methods have been reported for the estimation of Benfotiamine individually and combination with other drugs in formulation. Some Spectrophotometric 10,11 and HPLC 7 9 methods have been reported for the estimation of Metformin hydrochloride individually and combination with other drugs in formulation. MATERIALS & METHODS Apparatus The chromatography was performed on a Waters HPLC instrument equipped with UV detector and Peak LC 7000 software, Phenomenex Luna C 18 ( mm, 5 μ particle size) was used as stationary phase. Shimadzu Ax200 analytical balance and Sonicator Pci Ultrasonic 3.5L100H were used in the study. Preparation of standard stock solutions Accurately weighed quantities of benfotiamine (10 mg) and metformin hydrochloride (100 mg) were transferred to a separate 100 ml volumetric flasks, dissolved and diluted to the mark with mobile phase to obtain of 100μg/ml and 1000 μg/ml respectively. Preparation of calibration curve Calibration curves for these drugs were prepared individually. Aliquots of 0.5, 1, 1.5, 2, 2.5, 3, 3.5ml of benfotiamine (100 μg/ml) and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2 ml of metformin hydrochloride (1000 μg/ml) were transferred individually to the 10 ml of volumetric flasks and made up to the mark with mobile phase to get 5, 10, 15, 20, 25, 30, 35 μg/ml of benfotiamine, 50, 75, 100, 125, 150, 175, 200 μg/ml of metformin hydrochloride respectively. An aliquot (20 μl) of each solution was injected under the operating chromatographic conditions and responses were recorded. Calibration curves were constructed and the regression equations were calculated. The spiked solution was prepared by transferring 1.5 ml of benfotiamine (100 μg/ml) and 1ml of metformin hydrochloride (1000 μg/ml) to the 10 ml of volumetric flask and made up to the mark with mobile phase to get 15 μg/ml of benfotiamine and 100 μg/ml metformin hydrochloride. Sample preparation Tablet powder equivalent to 15mg of benfotiamine was weighed and transferred to 100ml standard flask. 88 RGUHS J Pharm Sci Vol 2 Issue 4 Oct Dec, 2012

3 Small amount of mobile phase was added to dissolve and then the volume was made up to the mark with mobile phase. It was filtered and sonicated. From this stock solution 1ml was transferred to the 10 ml volumetric flask and final volume was made to 10ml, contain 15μg/ml benfotiamine and 100μg/ml metformin hydrochloride. Prepared sample solution was analysed. (Table 3) Method validation The optimized Chromatographic method was completely validated according to the procedures described in ICH guidelines Q2 (R1) for the validation of analytical methods (ICH, 2005) (12). System suitability test System suitability test was carried out on freshly prepared mixed standard solution. Twenty μl of the standard solution was injected under optimized chromatographic conditions and system suitability parameters were evaluated. The values were shown in Table 1. Specificity Specificity of the HPLC method was demonstrated by the separation of the analytes from other potential components such as impurities, degradants or excipients. A volume of 20 μl of working placebo sample solution was injected and the chromatogram was recorded. No peaks were found at retention time of 2.29 and 3.84 min. Hence, the proposed method was specific for these two drugs. Linearity The linearity of calibration curves in pure solution was carried over the concentration range of 5 35 μg/ ml for benfotiamine and μg/ml for metformin hydrochloride through proposed HPLC method. Table 1: System Suitability Test Parameters System suitability parameters Results of the Proposed method Benfotiamine Metformin hydrochloride Retention time(min) Area Theoretical plate number Tailing factor Resolution factor Precision The precision of the method was determined by repeatability and intermediate precision (intra-day and inter-day). Repeatability The repeatability of the proposed method was ascertained by injecting six replicates of fixed concentration of these two drugs within the Beer s range and finding out the peak area by the proposed method. From this peak area %RSD was calculated. (Table 2) Intra-day precision Intra day precision was determined by injecting three different mixed concentrations (90 %, 100% and 110%) for three times in the same day. Peak area was measured and %RSD was calculated. (Table 2) Inter-day precision Inter-day precision was determined by injecting three different mixed concentrations (90 %, 100% and 110%) for three days in a week. Peak area was measured and %RSD was calculated. (Table 2) Accuracy For the accuracy of proposed method, recovery studies were performed by standard addition method Table 2: Validation parameters of the proposed method Results Parameter Benfotiamine Metformin hydrochloride Linearity (μg/ml) Slope(m) Intercept(c) Correlation co effi cient (r) Regression equation(y=mx+c) Y= x Y= x Repeatability(%RSD, n=6) Intra-day precision(%rsd n=6) Inter-day precision(%rsd,n=6) % Recovery Robustness Robustted Robustted LOD(μg/ml) LOQ(μg/ml) RGUHS J Pharm Sci Vol 2 Issue 4 Oct Dec,

4 Table 3: Analysis of formulation Brand name Drug Amount labelled (mg) Amount found (mg) %Recovery %RSD Benforce-M Benfotiamine Metformin hydrochloride at three different levels (50%, 100% and 150% of final concentration). A known amount of standard pure drugs were added to pre-analyzed tablet powder and the sample was then analyzed by proposed method. Results of recovery studies were found to be satisfactory. (Table 2) Robustness The robustness of the HPLC method was evaluated by analyzing the system suitability parameters after varying the ph of the Mobile phase (± 0.2), organic solvent content (±5%), wave length (±5 nm). None of the alterations caused a significant change in peak area RSD, tailing factor and theoretical plates. Although the changes in the retention times were acceptable. Limit of detection and Limit of quantification Limit of detection (LOD) and Limit of Quantification (LOQ) were determined by using the formula based on the standard deviation of the response and the slope. LOD and LOQ were calculated by using equations, LOD=3.3 s/s and LOQ=10 s/s, where s = standard deviation, S= slope of the calibration curve (Table 2). Results and discussions To develop the RP-HPLC method, several mobile phase compositions were tried. A satisfactory separation and good peak symmetry was obtained with Phenomenex Luna C 18 ( mm, 5μ) column and mobile phase comprising of acetonitrile: methanol: water: 0.1% OPA (40:20:35:5 %v/v) at a flow rate of 1.0 ml/min to get better reproducibility and repeatability. Quantification was achieved with UV detection at 249 nm based on peak area. The retention time for benfotiamine and metformin hydrochloride were found to be 3.84 and 2.29 min, respectively. The optimized method was validated as per ICH guidelines. The system suitability parameters observed by using this optimised conditions were reported in Table 1. A linearity range of 5 35 mg/ml with correlation coefficient was established for benfotiamine and μg/ml with correlation coefficient was established for metformin hydrochloride. The results of recovery study (99.14% to % for benfotiamine and % to % for metformin hydrochloride) suggest that the method has good recovery. The precision of the proposed method was Figure 3: Benfotiamine and Metformin hydrochloride Formulation Peaks. 90 RGUHS J Pharm Sci Vol 2 Issue 4 Oct Dec, 2012

5 carried in terms of the repeatability, inter-day and intra-day time periods. The low % RSD (<1) values of repeatability (0.33%, 0.28%), inter-day (0.48% 0.69% and 0.53 % 0.88%) and intra-day (0.32% 0.51% and 0.43% 0.67%) variations for benfotiamine and metformin hydrochloride, respectively, reveal that the proposed method is precise. The LOD and LOQ values for benfotiamine was found to be μg/ ml,0.4833μg/ml and for metformin hydrochloride was μg/ml, μg/ml. The results of robustness in the present method show no significant changes. The results of analysis of tablet indicated that no interference due to common tablet excipients was observed with the developed method. Therefore, the proposed method can be used for routine analysis of two drugs in their combined pharmaceutical dosage form. CONCLUSION The validation study shows that the developed method is accurate, sensitive and precise with acceptable correlation co-efficient, RSD (%) for simultaneous determination of benfotiamine and metformin hydrochloride in pharmaceutical dosage form. Moreover, the short run time of 10 minutes allows the analysis of a large number of samples in a short period of time. Additionally in this method, there was no interference from tablet excipients. So it can be concluded that RP-HPLC method can be used in the quality control department. REFERENCES 1. Sweetman SC. Martindale: The Complete Drug Reference. 33rd ed. London: Pharmaceutical Press; 2007; , Jan 25) 3. (cited 2012 Jan 25) Jan 25) 5. Vinodhini C, Kalidoss SA and Srinivasan M. Development of high performance liquid chromatographic method for the estimation of Benfotiamine in tablets. Indian drugs 2007; 44(4): Poongothai S, Ilavarasan R., Karrunakaran CM. Simultaneous and accurate determination of vitamins B 1,B 6,B 12 and Alpha-lipoic acid in multivitamin capsule by Reverse-Phase High performance liquid chromatographic method. Int J Pharm Pharm Sci. 2010; 2(4): Wajari MM, There AW, Tajne MR et al. Rapid and simple RP HPLC method for the estimation of Metformin in rat plasma. Indian J Pharm Sci. 2008; 70: Saeed Arayne M, Najma Sultana, Hashim Zuberi M. Development and validation of RP-HPLC method for the analysis of Metformin. Pak. J. Pharm. Sci. 2006; 19(3): Thamma Narendra Kumar, Kota Chandra Mohan Rao, Sreenivasulu R. et al. Novel Rp-hplc method for the estimation of Metformin hydrochloride in pharmaceutical dosage forms. IJSID 2011; 1 (3): Arayne MS, Najma S, Zuberi MH. Spectrophotometric Quantitation of Metformin in Bulk Drug and Pharmaceutical Formulations using Multivariate Technique. Indian J Pharm Sci. 2009; 71(3): Mubeen G, Noor K. Spectrophotometric method for analysis of Metformin hydrochloride. Indian J Pharm Sci. 2009; 71(1): ICH Q2 (R1) Validation of Analytical Procedures: text and methodology; RGUHS J Pharm Sci Vol 2 Issue 4 Oct Dec,

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