Abstract

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Title STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE BY RP-HPLC IN PHARMACEUTICAL DOSAGE FORM
Authors B. Sahithi Chowdary, M. Prasada Rao
Description The present study aims to develop a simple economical method for estimation of Azilsartan and chlorthalidone combined dosage form by RP-HPLC technique. Buffer used in this method was 0.1% OPA buffer of pH 2.5 used in the ratio of 40B:60A run through C18 BDS 250mm column with a flow rate of 1ml/min for 7min run time. The column was maintained at 30°C temperature and optimized wavelength was 220nm. Azilsartan eluted at 2.5min and Chlorthalidone at 3.5min retention time with 5.2 resolution. System suitability parameters like plate count and tailing factors were passed according to ICH guidelines. Repeatability of Azilsartan and chlorthalidone was found to be 0.4 and 0.34 respectively. Percentage recovery of azilsartan was 99.81% and of chlorthalidone was 99.71%. Linearity performed with range of 40-240µg/ml for azilsartan and 25-150µg/ml for chlorthalidone and correlation coefficient obtained was 0.999. Robustness was found to be within the limits i.e., less than 2. Stability studies were done and degraded was with the limits. A simple method was developed for estimation of Azilsartan and chlorthalidone. All the validation parameters were succeeded and were within the range. This method can be used in the regular analysis of Azilsartan and chlorthalidone combination dosage form.

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