Analytical Method Development and Validation of Perindopril and Amlodipine as Multicomponent Formulation by HPLC Method

Abstract

The work aims to develop and validate a simple, precise and accurate HPLC method per ICH guidelines. The linearity, specificity, Precision, and accuracy were within limits specified by the ICH guidelines. Hence the proposed system was found to be robust and precise. The objective of this study was to validate the simultaneous assay of Perindopril and Amlodipine by using High-Performance Liquid Chromatography (HPLC). Perindopril and Amlodipine were estimated with C18 Column (2.5 cm × 4.6 mm and five μm particle size) with a VWD detector. The mobile phase consists of Buffer Solution and Acetonitrile 55:45 v/v with a flow rate of 1 ml/min. The volume injected was 20 μL. The detection wavelength was 215 nm, respectively. The retention time of Perindopril and Amlodipine was found to be 3.40 min and 4.73 min. The system suitability and all essential validation parameters were meticulously completed. The LOD and LOQ for Perindopril were found to be 2.62 μg/ml and 7.95 μg/ml, respectively, and for Amlodipine, 1.06 μg/ml and 3.22 μg/ml, respectively. The analytical curve was linear (R2 = 0.999). The system exhibits sufficient accuracy with a relative standard deviation under 2%. The method showed good duplicability and recovery with % RSD less than 2%. The linearity, specificity, Precision, and accuracy were within limits specified by the ICH guidelines. Hence the proposed system was found to be robust and precise. The method has to be such that it takes less time development and the best accurate and complete results have been obtained. Hence the proposed method for simultaneous estimation of Perindopril and Amlodipine by HPLC was found to be robust and precise.