Capillary Electrophoresis Method Development for Simultaneous Determination of Atorvastatin and Ezetimibe from Solid Dosage Form

Abstract

Purpose: A simple, rapid, validated capillary zone electrophoresis (CZE) was established for the simultaneous estimation of atorvastatin and ezetimibe from solid dosage form.Method: The separation of both the drugs was accomplished on fused silica capillary (48cm × 50µmi.d.) using background electrolyte consisting of 2mM borate buffer (pH 9.3) and methanol (80:20 v/v) as BGE. All the capillary conditions were optimized and newly developed method was validated as per the ICH guidelines.Results: Good linear calibration was obtained for both the analytes ranging from 5 to 200µg/ml and 2 to 20 µg/ml for atorvastatin and ezetimibe respectively. The limit of detection and quantification were less than 2 µg/ml for both the analytes. Repeatability and intra-day precision were well within the acceptable range. The accuracy was expressed as percent recovery, which is found to be between 98.20% to 100.41%.Conclusion:The newly developed simple and validated CZE method was used for simultaneous determina tion of atorvastatin and ezetimibe from solid dosage form.

Keywords: CZE; atorvastatin; ezetimibe; validation; simultaneous deter mination