Analytical Method Development and Validation for Simultaneous Estimation of Candesartan Cilexetil and Hydrochlorothiazide in Tablet Dosage form Gaurkhede R.M.*, Chandewar A.V. P.W. College of Pharmacy, Dhamangaon road, Yavatmal. 445001 (M.S.) *Corresponding Author E-mail: rahulgaurkhede@gmail.com
Online published on 12 June, 2018. Abstract A simple, precise and reproducible stability indicating HPLC method has been developed and validated for simultaneous determination of Candesartan and Hydrochlorothiazide on an Hypersil BDS C18 column (150*4.6*5um) using a mobile phase consisting of phosphate buffer pH 5.4 and acetonitrile (65: 35) at flow 1.0 ml/min. Detection was carried out at 232nm. The method was validated with respect to specificity, accuracy linearity, precession, ruggedness and robustness parameters as per ICH guidelines. Linearity of the method was found to be 0.999; %RSD of precession was below 2.0%, recovery of added drug within 98–102%, System suitability parameters were within limit for Candesartan and Hydrochlorothiazide. This method is simple, accurate and precise, sensitive and applicable for analysis of Candesartan and Hydrochlorothiazide in tablet formulation. In Stress degradation studies were also carried out under stress testing conditions of acidic, basic, oxidative, photolytic, thermal and neutral degradation. Top Keywords Validation, ICH, RP-HPLC, Stress degradation study. Top |