Development and validation of stability indicating HPLC assay method for simultaneous determination of amlodipine besylate, olmesartan medoxomil and hydrochlorothiazide in tablet formulation

The purpose of the research described herein was to develop simple, precise and accurate isocratic stability indicating reversed phase HPLC assay method for determination of simultaneous determination of Amlodipine besylate, Olmesartan medoxomil and Hydrochlorothiazide solid dosage forms. Isocratic RP-HPLC method was developed on Phenomenex Gemini C18 250´ 4.6mm, 5μm column using mobile phase as 0.02M ammonium acetate buffer pH 4.5 - Acetonitrile (60:40, v/v) at a flow rate of 1.0 ml/min and the detection was carried out at 241 nm using photo-diode array detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The validation element investigated showed that the method has acceptable specificity, accuracy, linearity, solution stability, precision and robustness.
Author(s): Gaurang P. Pandya and Hitendra S. Joshi

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