validated reversed phase HPLC-method for the determination of olmesartan medoxomil in combination with hydrochlorothiazide

ABSTRACT

A simple, sensitive, accurate, and precise reverse phase HPLC method has been developed for the simultaneous determination of olmesartan medoxomil in combination with hydrochlorothiazide. The mobile phase consisted of acetonitrile and 50 mM ammonium acetate buffer adjusted to pH 3.5 in ratio of [6040, v/v], the stationary phase was a reverse phase silica column [25 cm x 4.6 mm ID, 5 micro m] with UV detection at 264 nm. The method was linear over the concentration range for olmesartan medoxomil 3.0-20.0 micro g ml[-1] and for hydrochlorothiazide 1.0-12.0 micro g ml[-1] used loratidine as an internal standard [IS]. Analytical recovery obtained was 99% [C.V= 1.9, n=6]. The validation of method was carried out using ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form