Development and Validation of Zero Absorbance Method for Simultaneous Estimation of Aliskiren and Amlodipine in Combined Dosage Form

A simple, accurate, precise, economical and reproducible method was developed for simultaneous estimation of aliskiren and amlodipine in Combined Pharmaceutical Dosage Forms. The excipients in the commercial tablet preparation did not interfere with the assay. At 360 nm, Amlodipine showed some absorbance while aliskiren showed zero absorbance so that amlodipine was estimated at 360 nm. While at 287 nm aliskiren showed some absorbance while amlodipine showed zero absorbance so that aliskiren was estimated at 287nm. Linearity in concentration range of 10-120 μg/mL for aliskiren and 4-28 μg/mL for amlodipine with the mean recoveries were 100.08±1.32 and 99.76±1.05 % for aliskiren and amlodipine, respectively. Validation of the proposed method was carried out according to ICH guidelines. Thus the present study gives an excellent method for the determination of the two drugs in combined dosage formulation without their prior separation.