Development And Validation of Impurity Profiling in Amlodipine Besylate by High Performance Liquid Chromatography

In present study, simple, cost effective, time saving, gradient, accurate and reproducible HPLC analytical technique was developed and validated for the simultaneous quantification of genotoxic and process impurities of Amlodipine Besylate. The method was developed on Agilent HPLC C18 column, with mobile phase of 10 mM Sodium dihydrogen phosphate monohydrate in water adjusted to pH ± 3.5 with Orthophosphoric acid and 100% Acetonitrile. The flow rate of 1.2 ml per min was maintained and column oven temperature of 15°C. Detection done at 220 (for genotoxic impurities) and 280 nm (for process impurities) using UV detector. The method was validated for specificity, system suitability, Linearity, Precision, LOD, LOQ and Accuracy. Analytical method passed the acceptance criteria of specificity and system suitability. LODs for genotoxic (0.085 ppm and 0.084 ppm) and process (0.754 ppm and 0.6945 ppm) were well within acceptance limit. Similarly, LOQs for genotoxic (0.254 ppm and 0.252 ppm) and process (2.261 ppm and 2.084 ppm) were also well within acceptance limit. Both genotoxic and process impurities showed excellent linearity with R2 of 0.999 for each impurity. The precision and accuracy parameters were also found to be well within acceptable limit. The results confirmed that the method is accurate, linear and reliable for the quantitative estimation of impurities in single method at time, cost, manpower and usage of solvents.