Abstract

SIMULTANEOUS ESTIMATION OF ALISKIREN AND AMLODIPINE BY RP-HPLC AND ITS VALIDATION

Sri Lakshmi D.*, Jane T Jacob, Srinivas D and Satyanarayana D

Abstract

A simple, accurate, economical and precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous determination of Aliskiren and Amlodipine. The separation was achieved on Intersil C18 column (250 x 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of Methanol: KH2PO4 (80:20) in an isocratic mode, at a flow rate of 1 ml/min. The detection was monitored at 239 nm. The retention time of Aliskiren and Amlodipine were 2.869 min and 3.942 min respectively. The linearity was found to be in the range of 20-80 μg/ml for Aliskiren and Amlodipine respectively with correlation coefficient of 0.999. The proposed method was validated according to ICH guidelines for parameters like linearity, accuracy, precision and specificity. All validation parameters were within the acceptable range. The developed method was successfully applied for the estimation of Aliskiren and Amlodipine in pure and pharmaceutical dosage form.

Keywords: Aliskiren, Amlodipine, RP-HPLC, Validation, Simultaneous estimation, ICH guidelines.