Simultaneous Determination and Validation of Olmesartan Medoxomil, Amlodipine Besilate and Hydrochlorothiazide in Combined Tablet Dosage Form Using RP-HPLC Method

Abstract

A simple, accurate and precise RP- HPLC method has been developed for the simultaneous estimation of olmesartan medoxomil (OLME), amlodipine besilate (AMLO) and hydrochlorothiazide (HCTZ) in commercially available tablet formulations. The chromatographic separation was achieved on instrument Shimadzu LC 10 AT VP, Japan, equipped with photodiode array detector (PDA) SPD-10 AVP, attached with a class M 10 A software, (version 1.6) and Phenomenex Luna C₈ (25 cm × 4.6 mm i.d. × 5 μm) column using acetonitrile: phosphate buffer (pH 4 ± 0.1) (40:60 % v/v) as mobile phase at a flow rate of 1.0 mL/min. Quantitation was carried out at 258, 237 and 270 nm for Olmesartan medoxomil, amlodipine besilate and hydrochlorothiazide respectively. The method was validated as per ICH guidelines. The method may be applied for the routine simultaneous laboratory analysis of the above mentioned drugs in tablet dosage form.