摘要:
目的： 建立复方酮康唑凝胶剂中酮康唑和丙酸氯倍他索的含量测定方法。 方法： 采用高效液相色谱法,色谱柱为Hypersil ODS2 C18柱,甲醇-0．2%三乙胺（醋酸调pH至6．9,V：V=75：25）为流动相,流速1．0 mL/min．检测波长239nm。 结果： 酮康唑在10．08～201．16μg/mL浓度范围内呈良好的线性关系,r=0．9999；丙酸氯倍他索在0．251～5．02μg/mL浓度范围内呈良好的线性关系,r=0．9998。酮康唑的平均回收率为99．59%,RSD为0．77%；丙酸氯倍他索的平均回收率为100．76%,RSD为1．18%。 结论： 本方法分离度好,简便,准确,适用于复方酮康唑凝胶剂中2组分的同时测定,可作为产品的质量控制方法。
Abstract:
Objective: To establish a method for simultaneous determination of ketoconazole and clobetasol propionate in compound ketoconazole gel. Methods: HPLC method was developed.Chromatographic conditions included Hypersil ODS2 C18 column and the mo- bile phase was methanol-0.2% triethylamine（adjust with acetic acid to a pH of 6.9,V:V=75:25）.The flow rate was 1.0 mL/ min and the UV detection wavelength was at 239 nm. Results: Ketoconazole had a good linearity（r=0.9999） in the range of 10.08～201.16μg/mL,its average recovery was 99.59%（RSD=0.77%）.Clobetasol propionate had a good linearity（r=0.9998） in the range of 0.251～5.02μg/mL,its average recovery was 100.76%（RSD=1.18%）. Conclusion: The method was simple, sensitive and accurate for simultaneous determination of the two constituents in compound ketoconazole gel.
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