Abstract

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR AMLODIPINE BESYLATE AND NEVIRAPINE IN BULK AND TABLET DOSAGE FORM USING ABSORPTION RATIO METHOD

Sathis Kumar Dinakaran, Narayudu Yandamuri*, L P S Nainesha Allada

ABSTRACT

A simple, economic, and accurate absorption ratio method was developed for the simultaneous estimation of Amlodipine besylate (AML) and Nevirapine (NEV) in bulk and tablet dosage form. 0.1M HCl was used as a diluent to dissolve AML and NEV. The absorptions were observed at 252 nm (isobestic point) and 295 nm (λmax of NEV), which were selected based on overlapping spectra of AML and NEV. The linearity range was found to be 3-7 μg/ml at 252 nm for AML (r2=0.9995±0.0005) and 295 nm for NEV (r2=0.9985±0.0012). The method was found to be simple, precise, accurate and rapid for the simultaneous determination of AML and NEV in bulk and tablet dosage form using absorption ratio method. Recovery study was performed to confirm the accuracy of the methods. The methods were validated as per ICH guidelines.

Keywords: Amlodipine besylate, Nevirapine, Spectrophotometric analysis