Development and Validation of a simple and rapid RP-HPLC method for the simultaneous estimation of Amlodipine and Atorvastatin in Tablet Dosage Form

摘要

A simple and rapid reversed phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Amlodipine and Atorvastatin in tablet dosage form. The separation was achieved on a Waters Symmetry C-18 column, (150mm x 3.9mm x 5μ particle size) using Acetonitrile: KH2PO4 buffer (pH 5.8) in the proportion of 45:55, v/v as mobile phase, at a flow rate of 1.0 mL/min. Detection was carried out at 254nm using VW detector. Amlodipine and Atorvastatin gave a retention time of 2.2±0.2 min and 3.2±0.2 min respectively. The developed method was validated for specificity, linearity, accuracy, precision and robustness as per ICH guidelines. The method was found to be specific as there was no interference seen in blank and placebo injections at the retention time of the drugs. The calibration curves were found to be linear with r2 = 0.999 for both the drugs. The method was found to be accurate as the mean percent recovery of Amlodipine and Atorvastatin was within the acceptance criteria. The method was found to be precise with %RSD less than 2. The method was found to be robust as small, deliberate changes in chromatographic conditions did not alter the results of analysis significantly. The method was applied in analysis of marketed formulation and the % assay was found to be within limits.