Development of Validated Stability Indicating Assay Method by RP-HPLC for Simultaneous Estimation of Azilsartan Medoximil and Chlorthalidone in Their Bulk and Combination Form

S. Priyanka Yadav*¹, P. Sowjanya², Dr. Gampa Vijaya Kumar^3
1,2KGR Institute of Technology and Management,   Rampally,   Kesara,   Rangareddy, Telangana, India,
³Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India

 A B S T R A C T
Method was established for simultaneous estimation of Azilsartan medoxomil and Chlorthalidone by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Azilsartan medoxomil and Chlorthalidone by using Agilent C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Methanol: sodium taurocholate (70:30%v/v) has been selected as mobile phase.  If any buffer selected buffer pH should be between 2 (as to maintain biorelevant media specifications) Detection wave length was 238nm. The instrument used was Shimadzu LC-20 AD, SPD-M20A diode array detector, LC 20 software. The retention times were found to be 2.443 mins and 2.918 mins. The % purity of Azilsartan medoxomil and Chlorthalidone was found to be 100.7% and 101.4% respectively. The system suitability parameters for Azilsartan medoxomil and Chlorthalidone such as theoretical plates and tailing factor were found to be 1.7, 2114 and 1.7, 2931 the resolution was found to be 8.0.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)).
Keywords: Agilent C18, Azilsartan medoxomil and Chlorthalidone, RP-HPLC method