DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING ASSAY FOR AZILSARTAN KAMEDOXOMIL IN SOLID DOSAGE FORMS.

A RP-HPLC method was developed and validated for simultaneous determination of kamedoxomil in pharmaceutical preparations such as Edarbi® 40mg tablets. In order to develop stability indicating assay method initially the drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis degradation. Degradation of the drug was observed in acid, alkaline photolysis and peroxide conditions. The Method was validated as per US-FDA guidelines for the estimation of Azilsartan medoxomil using (Kromasil) C18 (250 × 4.6 mm, 5 ?) column with 0.025 M ammonium acetate (pH 5.0): acetonitrile (30: 70 %, v/v) as mobile phase, at a flow rate of 2 ml/min. The detection was performed at 254 nm. The calibration curve was found linear in the range of 10-70 µg/ml. with correlation coefficient >0.999. During calibration experiments. accuracy and precision studies, intra-day and inter-day, % relative error was found between ±15 and % RSD was less than 15 %. The developed method meets the requirements of US-FDA guidelines.