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.