Quantitative work in HPLC

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1 Quantitative work in HPLC Dr. Shulamit Levin Medtechnica Dr. Shulamit Levin, Medtechnica 1

2 Quantitative work in HPLC Dr. Shulamit Levin Medtechnica Data Handling Analytical Chemistry - Science of making quantitative measurement Raw data is manipulated and reported correctly to give a realistic estimate of the uncertainty in a result. Chemist's Concerns REFERENCE STANDARDS: Maximize Confidence Established source and known grade (DMF or COA) Accuracy of the data Precision or reproducibility of the data Sensitivity of detection Selectivity of the separation Ruggedness of the method % purity from assay will be taken into account in the calculations. % residual compounds (GC, heavy metals, inorganic VDOWVZDWHUUHVLGXDOVROYHQWVZHLJKWORVV? Dr. Shulamit Levin, Medtechnica 1-4

3 Choice of Standardization: External or Internal Measurement of Area - Integration Detector Signal Area = Abs x dt Simple formulations and sample preparation: external standard Gas chromatography, bio-studies or complex medium and complex sample preparation: internal standard Time Peak Detection: Peak Apex Working Curve A plot of the analytical signal (the instrument or detector response) as a function of analyte concentration, using a series of standards of known concentration. Peak Height Area Start of chromatogram Peak Start Retention Time Constructed Baseline Peak End Conc The working curvesare then used to determine the concentration of an unknownsample or to calibrate the linearity of an analytical instrument. Dr. Shulamit Levin, Medtechnica 5-8

4 Choice of Standardization: External or Internal External Standard Amount Std Amount Unk Response Std Response Unk Choice of Standardization: External or Internal Internal Standard C Int. Std. D Amount Unk = Amount Std Response Std x Response Unk Response Std Amount Std Amount Istd Response Std Response Istd Amount Std Amount Unk Amount Istd Response Unk Response Istd 12,000/6000 0/ 11,000/5800 Amt Bi/ Linear Regression for the Equation: Bi Ci Int. Std. 0 B C Int. Std. y = mx + b 11,000 5,800 12,000 6,000 Unknown Standard (11,000/5,800) x (0/) x = Amt Bi = ,000/6000 Linear regression uses the method of least squares to determine the best equation describing a set of x and y data points. Dr. Shulamit Levin, Medtechnica 9-12

5 Standard Addition Due to matrix effects the analytical response for an analyte in a complex sample may not be the same as for the analyte in a simple standard. Parameters To Monitor - Validation Precision (Ruggedness) Accuracy Signal Limit of detection Limit of quantitation Linearity (range) Selectivity Conc. Robustness PRECISION AND ACCURACY Overlaid Chromatograms Good Precision Peak1 GOOD PRECISION POOR ACCURACY POOR PRECISION POOR ACCURACY Peak2 Peak GOOD ACCURACY POOR PRECISION GOOD PRECISION GOOD ACCURACY SampleName 2690_Eau40_60CH3OH_2mm_D Vial 4 Injection 1 SampleName 2690_Eau40_60CH3OH_2mm_D Vial 4 Injection 2 SampleName 2690_Eau40_60CH3OH_2mm_D Vial 4 Injection 3 SampleName 2690_Eau40_60CH3OH_2mm_D Vial 4 Injection 4 SampleName 2690_Eau40_60CH3OH_2mm_D Vial 4 Injection 5 SampleName 2690_Eau40_60CH3OH_2mm_D Vial 4 Injection 6 Dr. Shulamit Levin, Medtechnica 13-16

6 Quality Control VIAL SAMPLE NAME INJ VOL No of Inj Function Method Run Time Sample Dilution Weight 1 Blank Inject Samples LC Demo Method Set System Inject Samples SST Method Set Suitability Clear LC Demo Method Set Calibration 3 Std Inject Standards LC Demo Method Set Std Inject Standards LC Demo Method Set Accuracy check Report LC Calibration Report Report Standard Comparison Clear LC Demo Method Set Calibration 1 Std Inject Standards LC Demo Method Set Unk Inject Samples LC Demo Method Set Unk Inject Samples LC Demo Method Set Unk Inject Samples LC Demo Method Set Unk Inject Samples LC Demo Method Set Unk Inject Samples LC Demo Method Set Unk Inject Samples LC Demo Method Set Std Inject Standards LC Demo Method Set Clear LC Demo Method Set Calibration Calibrate LC Demo Method Set Limit of Detection: Parameters To Monitor - Validation h signal h noise h signal = 2 x h noise Limit of Quantitation: h signal = x h noise LOQ - RSD < 5-% Precision (Ruggedness) Accuracy Limit of detection Limit of quantitation Linearity (range) Selectivity Robustness Parameters To Monitor - Validation Linearity to 2 Precision (Ruggedness) Accuracy Limit of detection LINEARITY 5-6 concentrations of the reference standards (in duplicates or triplicates) below and above the expected concentration of the samples (20% - 120%) Concentration y = ax + b Limit of quantitation Linearity (range) Selectivity Robustness RESULTS: Slope Intercept Correlation coefficient Range of linearity in concentration units. Dr. Shulamit Levin, Medtechnica 17-20

7 nm Parameters To Monitor - Validation Peak Purity Analysis Spectra at apex and inflection points are displayed Spectrum at maximum impurity is different Maximum Impurity Photodiode Array Technology Precision (Ruggedness) Accuracy Limit of detection Limit of quantitation Stability Indicating Method Stress Studies The drug substance, the dosage form and the placebo are stressed, using the following stress agents: Spectral Analyses Library Matching Compound identification Coelution detection Peak Purity Analysis Peak purity/peak homogeneity Coelution detection Linearity (range) Selectivity Robustness Acid Base Oxidizer (H2O2) UV radiation Heat. Parameters To Monitor - Validation Methods Transfer: 3 HPLC Systems 3 Systems in USA 2 in Europe 3 Chemists Dial-a-mix, 60:40 MeOH:H2O 1 ml/min? & Precision (Ruggedness) Accuracy Limit of detection Limit of quantitation Linearity (range) Methods Transfer: 3 HPLC Systems 3 Systems 1 in USA 2 in Europe 3 Chemists Mix by HPLC, 60:40 MeOH:H2O 1 ml/min 30 C Selectivity Robustness - Reproducibility Dr. Shulamit Levin, Medtechnica 21-24

8 Imp1 Imp1 Imp1 Column Batch-to-Batch Reproducibility Imp2 Imp2 Imp2 Imp3 Imp3 Imp3 Batch 8 Imp4 Imp4 Imp4 20 Batch 9 20 Batch Sample: AZT Injection: 150 ml of 0.5 mg/ml solution Column: Symmetry C18, 3.9 mm x 150 mm 7HPSHUDWXUH?& Mobile Phase: 6% MeOH/ 6% THF/ 88% mm potassium phosphate buffer, ph 2.5 Flow rate: 1.7 ml/min Detector: UV at 268 nm Robustness of the chromatographic method Parameters Varied : Solvent strength in the mobile phase, Temperature, Flow rate, ph of the mobile phase, Ionic strength in the mobile phase, Sample diluent, Injection volume, Wavelength of detection. The parameter measured: Rresponse (area/amount) Retention time, Selectivity and/or resolution. AZT: Robustness Testing 6% Methanol, 6% THF Robustness of the sample preparation procedure Imp. 1 Imp. 2 Imp. 3 ph 2.3 Imp. 4 PARAMETERS CHANGED: Duration of extraction, Imp Imp Imp Imp Time [min] Imp Imp Imp Imp. 4 ph 2.5 ph 2.7 Extraction medium, Filtration type, Temperatures. PARAMETER MEASURED: Accuracy Time [min] Dr. Shulamit Levin, Medtechnica 25-28

9 METHOD VALIDATION REFERENCE STANDARDS: Established source and known grade (DMF or COA) METHOD VALIDATION Summary CATEGORY I Drug substance VALIDATION: Method suitability without LOD or LOQ % purity from assay will be taken into account in the calculations. % residual compounds (GC, heavy metals, inorganic salts, water, residual solvents, weight loss). CATEGORY I I Impurities or degradation compounds VALIDATION: Complete procedure of method-suitability. If limit of purity is needed: only specificity, LOD and ruggedness. CATEGORY III Performance and potency of the drug product (dissolution). VALIDATION: Only precision and ruggedness are needed. Measurement of Area - Integration Detector Signal Area = Abs x dt Measurement of Area: Peak Integration: Peak Detection Peak Apex Peak Height Start of chromatogram Peak Start Constructed Baseline Peak End Retention Time Time Dr. Shulamit Levin, Medtechnica 29-32

10 Measurement of Area: Peak Integration: Data Bunching 15 = Minimum Number of points to define a peak Measurement of Area: Peak Integration - Peak Start Bunching B = (WxS)/15 Data points Slope 1 = (B2-B1)/(t2 -t1) B1 Slope 2 = (B3 -B2)/(t3-t2) B3 B2 Threshold value Average Slope Measurement of Area: Peak Integration - Peak End Measurement of Area: Peak Integration - Peak Apex Average Slope Threshold value Slope 2 = (B3 -B2)/(t3-t2) B3 B2 Slope 1 = (B2 -B1)/(t2-t1) B1 Slope 2 = (B3-B2)/(t3-t2) Slope 1 = (B2-B1)/(t2-t1) Dr. Shulamit Levin, Medtechnica 33-36

11 Integration of Small Peaks PW=15 Area= % PW=60 Area=25660 FS = Peak width changed Threshold set at Thresh.=300 Area= % Thresh.= 20 Area=25660 FS = Peak width set at 30 sec Threshold changed Dr. Shulamit Levin, Medtechnica 37-40

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