Single RP-HPLC Method for Assay And In Vitro Dissolution Study of Candesartan Cilexetil in Tablets

Abstract

Single RP-HPLC method for assay and in vitro dissolution study of Candesartan cilexetil in tablets was developed and validated. The separation was accomplished on Brava BDS C18 (150 mm X 4.6 mm), 5 , column under isocratic mode. The optimized mobile phase was Buffer: Acetonitrile (50:50v/v) for both assay and in vitro dissolution study. The flow rate optimized was 1.0 ml/min with detection at 254 nm. The method is validated as per ICH Guideline Q2 (R1) for specificity, linearity, accuracy, precision, robustness, system suitability and solution stability. The linear regression analysis data for the calibration plots showed good linear relationship with concentration range of 35-65 μg/ml for assay determination, 0.44-2.64 μg/ml for in virto dissolution. The developed method was simple, specific, accurate and precise. Thus the developed method can also be applicable to the routine analysis of Candesartan Cilexetil in marketed formulations.