Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE IN PHARMACEUTICAL DOSAGEFORM

K. Purnachander*, B. Babu Rao, B. Anil Kumar, V. Shashanka and A. Varaprasad

Abstract

A RP-HPLC method was developed and validated for simultaneous determination of Olmesartan Medoxomil and amlodipine besylate in pharmaceutical dosage form. Separation was achieved on hypersil C18 (150mm X 4.6mm X 5μ) using a mobile phase consisting of0.1% Orthophosphoric acid: Methanol (60:40) at a flow rate of 1mL/min and UV detection at 254nm. Linearity was observed over the concentration range of 50 to 150 μg/ ml for bothr olmesartan medoxomil and amlodipine besylate. The average percentage recovery of the method was 101% for olmesartan medoxomil and 98% for amlodipine besylate. The method was validated as per ICH guidelines.

Keywords: Olmesartan Medoxomil, Amlodipine Besylate, ICH, RP-HPLC, Validation.