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目的:建立RP-HPLC法测定复方酮康唑乳膏(皮康王)中的酮康唑、丙酸氯倍他索的含量。方法:用THERO Hylicerm ODS C_(18)(250mm×4.6mm,5μm),流动相为甲醇-0.02mol·L~(-1)磷酸二氢钾溶液(72:28)(用氨水调pH到7.2),流速1. 0ml·min~(-1),检测波长240nm。结果:酮康唑和丙酸氯倍他索的线性范围分别为2.5～25.0μg(r=0.999 9)和0.07～0.66μg(r =0.999 8),平均回收率分别为100.0%(RSD 0.1%)和99.6%(RSD 0.4%)(n=6)。结论:方法专属和准确,可作为复方酮康唑乳膏的质量控制。
OBJECTIVE: To establish a RP-HPLC method for the determination of ketoconazole and clobetasol propionate in compound ketoconazole cream (Picicon). METHODS: The mobile phase consisted of methanol-0.02mol·L -1 potassium dihydrogen phosphate solution (72:28) (adjusted to pH 7.2 with ammonia water) by using THERO Hylicerm ODS C 18 (250 mm × 4.6 mm, 5 μm) ), Flow rate 1. 0ml · min ~ (-1), detection wavelength 240nm. Results: The linear ranges of ketoconazole and clobetasol propionate were 2.5 ~ 25.0μg (r = 0.999 9) and 0.07 ~ 0.66μg (r = 0.999 8) respectively. The average recoveries were 100.0% (RSD 0.1% ) And 99.6% (RSD 0.4%) (n = 6). Conclusion: The method is specific and accurate and can be used as the quality control of compound ketoconazole cream.