Simultaneous Determination of Ketoconazole and Miconazole Mitrate in Compound Toconazole Gels by HPLC / 中国药师

ABSTRACT

Objective: To establish a method for the determination of ketoconazole and miconazole nitrate in compound ketocon-azole gels. Methods:An HPLC method was developed. A Hypersil BDS C18 column(416 mm × 200 mm,5μm) was used, the mobile phases consisted of 0. 5% ammonium acetate solution-methanol(containing 0. 2% triethanolamine) (20∶80), the flow rate was 1. 0 ml ·min-1 , the detection wavelength was set at 230nm, the column temperature was 30℃ and the injection volume was 20μl. Results:There was a good linear correlation within the range of 5. 1-510. 0 mg·L-1 for ketoconazole (r=0. 999 9) and 50. 0-500. 0 mg·L-1 for miconazole nitrate (r=0. 999 9), the average recovery for ketoconazole and miconazole nitrate was 100. 3%(RSD=0. 38%, n=6) and 99. 9%(RSD=0. 79%, n=6), respectively. Conclusion:The method is simple, rapid, accurate and sensitive, and can pro-vide a method for controlling the quality of compound ketoconazole gels.