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 liner 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 determination of atorvastatin and ezetimibe from solid dosage form.
Key words: CZE, Atorvastatin, Ezetimibe, Validation, Simultaneous determination.