Optimized RP-HPLC Method for the Quantification and Validation of Amlodipine and Irbesartan

Abstract

This study details the optimization and validation of an HPLC method for the simultaneous quantification of Amlodipine and Irbesartan in tablet formulations. Using a Methanol: Water (0.1% Orthophosphoric Acid) mobile phase in a 25:75 ratio and an Agilent C18 column, the method was optimized for effective separation. Validation was conducted according to ICH guidelines, with the method exhibiting excellent linearity for both drugs (R² > 0.997), precise results with low %RSD, and high accuracy as evidenced by recovery studies. The method proved robust under various tested conditions, confirming its suitability for routine quality control of Amlodipine and Irbesartan in pharmaceutical products.