HPTLC method for estimation of Olmesartan medoxomil in tablet formulation with stability studies

Abstract

A rapid resolution high performance thin layer chromatography (HPTLC) method has been developed and validated for estimation of Olmesartan medoxomil in tablet formulations. This paper describes accurate, precise, specific and reproducible method and its degradation products, related impurities for assessment of purity of bulk drug and stability of its tablet formulations. The method involve silica gel 60 F254 high performance thin layer chromatography and densitometric detection at 264 nm using toluene - acetonitrile- methanol - ethyl acetate - acetic acid (5:3.5:0.3:1:0.3 v/v/v/v). Calibration curve ranges between 300-800 ng/spot-1 Olmesartan medoxomil. Experimental design was involved forced degradation of drug, optimization of mobile phase, detection made and other chromatographic phase and study of linearity range. The total time for chromatographic separation was 6 min with a total analysis time 15 min. The proposed method was validated for its linearity, precision, recovery studies and robustness.