Abstracto

Determination of Azilsartan Medoximil and Chlorthalidone in tablets exposed to forced degradation by using RP-HPLC

T Hemant Kumar, Ayesha Begum, D Gowri Sankar

An RP-HPLC method was developed which was simple, specific and precise accurately and was validated for the simultaneous estimation of Azilsartan Medoxomil and Chlorthalidone by following forced degradation studies in pharmaceutical formulation. The method has been developed using Enable C 18G column (250 × 4.6 mm, 0.5 μm) and a mobile phase comprising of acetonitrile and 0.1% trifluoroacetic acid in water at the ratio of 40:60%v/v with a flow rate of 0.8 mL/min. UV detection was carried out at 240 nm. The retention time for Azilsartan Medoxomil and Chlorthalidone were found to be 6.982 and 7.748 min respectively. The proposed method was validated for various parameters like linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 5-80 μg/ml for Azilsartan Medoxomil (r2=0.9995) and 2.5-25 μg/ml for Chlorthalidone(r2=0.9973). The% RSD for Intraday and Interday precision was found as 0.41 and 0.41 for Azilsartan Medoxomil and 0.32 and 0.47 for Chlorthalidone respectively. The LOD and LOQ were found as 0.0189 μg/ml and 0.0305 μg/ml for Azilsartan Medoxomil and LOD and LOQ were found to be 0.1109 and 0.3522 μg/ml for Chlorthalidone respectively. Azilsartan Medoxomil and Chlorthalidone have been subjected to stress conditions of degradation including acidic, alkaline, oxidative, and thermal and photolysis.