Comparison of capillary zone electrophoresis and high performance liquid chromatography methods for quantitative determination of ketoconazole in drug formulations.

A capillary zone electrophoresis (CZE) and a high-performance liquid chromatography (HPLC) method have been developed for identification and determination of ketoconazole, an imidazole antifungal, in pharmaceutical preparations. The suitabilities of both methods for quantitative determination of ketoconazole were approved through validation specification such as linearity, precision, accuracy, limit of detection and quantification. The proposed methods were used for determination of ketoconazole in commercial pharmaceutical dosage forms (tablets and creams). Under described conditions, CZE method is more selective, while the HPLC method is more sensitive. Both methods are rapid (tR(CZE)=5.14 min and tR(HPLC)=2.66 min), which is important for routine application. However, the HPLC method provides a repeatability of the quantitative analysis of ketoconazole in drug formulations below 1.5% relative standard deviation (R.S.D), while the repeatability of the CZE method is in the order of 2-3% R.S.D. Copyright 2004 Elsevier SAS