RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF AZILSARTAN MEDOXOMIL API AND ITS APPLICATION TO FORCED DEGRADATION STUDIES

A simple, specific and accurate stability indicating reverse phase liquid chromatographic method was developed for the estimation of Azilsartan Medoxil in its bulk form. Azilsartan medoxil is an angiotensin-II receptor antagonist used in the treatment of hypertension. Chromatography was performed using C18 column Qualisil Gold (250 X 4.6 mm, 5μm) with mobile phase consisting 0.2% trifluroacetic acid in acetonitrile and 0.2% trifluroacetic acid in MilliQ water in the ratio of 62:38.The pH was adjusted to 3 with orthophosphoric acid. The detection was carried out at 248nm and retention time (RT) of Azilsartan Medoxil was found to be 7.353min.The developed method was statistically validated for linearity(20-120 ?g/ml) and the results of precision, accuracy, specificity, LOD(0.0186?g/ml), and LOQ(0.0613 ?g/ml) were well within limits. Azilsartan Medoxil was subjected to stress conditions including acidic, alkaline, oxidative, photolysis and thermal degradation and the results showed that it was highly sensitive to alkaline conditions followed by liable to photolytic, oxidative, thermal, acidic and neutral stress conditions. The degraded products were well resolved from the analyte peak with significant difference in their RT values. The method was validated as per ICH guidelines. Keywords: Azilsartan medoxil, Reverse phase, ICH, Chromatography