Development and validation of RP-HPLC method for the simultaneous determination of azilsartan medoxomil and...

The fixed dose combination of azilsartan medoxomil and chlorthalidone has been effectively used to treat hypertension. Development of a specific and accurate Reverse-Phase HPLC method for simultaneous estimation of AZL and CLR was main objective of this study that was used for simultaneous quantification of these drugs in human plasma. The method used 30:70 acetonitrile and water as mobile phase, thermo-scientific ODS hypersil C₁₈ column (250 × 4.6 mm, 5µm),1.2mL/min flow rate analyzed at 230nm. The retention time was 1.61 and 4.12 for AZL and CLR respectively. All the validation parameters of proposed method were performed. Linearity was found 0.9991 R² for the concentration of 3-22µg/ml for CLR and 0.9997 for concentration 10-70µg/ml for AZL. The inter-day and intraday precision were found 0.37 and 0.20 for AZL and 0.83 and 0.34 for CLR. LOD of AZL and CLR was 0.010µg/mL and 0.016µg/ml while LOQ was 0.032µg/mL and 0.048µg/mL for AZL and CLR respectively. The method was found to be effective in AZL and CLR quantification for pharmacokinetic study in human blood plasma.