RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions

Abstract

A simple, sensitive and precise RP-HPLC-DAD method was developed and validated for the determination of olmesartan medoxomil (AT-II receptor blocker) in the presence of its degradation products. Olmesartan medoxomil and all the degradation products were resolved on a C18 column with the mobile phase composed of methanol, acetonitrile and water (60:15:25, V/V/V, pH 3.5 by orthophosphoric acid) at 260 nm using a photodiode array detector. The method was linear over the concentration range of 1-18 μg mL-1 and precise with RSD < 1 % in intra- and inter-day study. Excellent recoveries of 99.3 ± 0.9 to 100.8 ± 1.2% proved the accuracy of the method. Developed method was specific, as indicated by chromatographic resolution > 2.0 for each peak and sensitive with LOD 0.03 μg mL-1 and LOQ 0.1 μg mL-1. The method was used to study the drug degradation behavior under forced conditions. Four degradation products (DP-I, II, III, IV) were formed during the degradation study in 0.1 mol L-1 HCl whereas only DP-I, II and III were formed in water, 0.01 mol L-1 NaOH and 3% H2O2. No significant thermal or photolytic degradation was observed in solid drug. The method was applied successfully for the assay of olmesartan medoxomil in the tablet dosage form.