高效液相色谱法测定酮甲霜中酮康唑含量

Determination of Ketoconazole in Compound Ketoconazole Cream by HPLC

目的建立测定酮甲霜中酮康唑含量的高效液相色谱法。方法色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(74∶26),检测波长为239 nm。结果酮康唑质量浓度在30～70μg/mL范围内与峰面积线性关系良好,回归方程为Y=24 616X-135 469,r=0.999 5(n=5);平均回收率为99.89%,RSD=0.93%(n=9)。结论该方法简便、准确,可用于酮甲霜中酮康唑的含量测定。

Objective To establish the HPLC method for the determination of ketoconazole in Compound Ketoconazole Cream.Methods The ana-lytical column was Diamonsil C18（250 mm × 4.6 mm,5 μm）.The mobile phase consisted of methanol-water（74 ∶ 26）.The detection wave length was 239 nm.Results The linear range of ketoeonazole was 30-70 μg /mL（r = 0.999 5,n = 5）.The average recovery rate was 99.89%,RSD = 1.40%（n = 9）.Conclusion The method is simple and accurate,which can be used for the quality control of Compound Ketoconazole Cream.