Analytical Method Development and Validation for Assay of Fimasartan Potassium Trihydrate and Chlorthalidone in Tablet Dosage Form by Using RPHPLC

— Present work was to develop and validate novel, specific, linear, accurate and precise analytical method for quantitative estimation of Fimasartan Potassium Trihydrate and Chlorthalidone in tablet dosage form using RP-HPLC. Prontosil C18 (250 mm ×4.6 mm,5µm) column utilized for this chromatographic analysis. The mobile phase of Potassium Phosphate Buffer (pH 3) and ACN in gradient mode with flow rate of 1.5 ml/min was used and the injection volume was 20 µL. The detection wavelength was 230 nm over 8-minute run time. The retention time of Fimasartan Potassium Trihydrate and Chlorthalidone was 5.0 and 2.6 respectively. Based on ICH guidelines above method were validated. The percentage Assay found was 100.6 % for Fimasartan Potassium Trihydrate and 99.5 % for Chlorthalidone which were matching the label claim of tablet of 120 mg and 25 mg Fimasartan Potassium Trihydrate and Chlorthalidone respectively. The correlation coefficient for the two drug was 0.99 which satisfied the validation acceptance criteria. The experimentally determined values for LOD and LOQ for Fimasartan Potassium Trihydrate was 1.37, 4.16 and for Chlorthalidone was 0.39, 1.21 respectively