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目的:建立HPLC法同时测定复方环丙沙星滴耳液中盐酸环丙沙星和氢化可的松的含量。方法:采用ODS为固定相;甲醇乙腈0.05mol·L-1枸椽酸溶液(三乙胺调节pH至3.5)(60∶7∶33)为流动相,检测波长为245nm。结果:本方法同时测定2组分含量。盐酸环丙沙星和氢化可的松分别在125~750μg·ml-1和12.5~75μg·ml-1浓度范围内,峰面积与其浓度呈良好的线性关系,平均回收率和RSD分别为100.15%,0.37%;100.16%,0.47%。结论:本法简便、快速、结果准确,适用于该制剂的质量分析检验。
Objective: To establish an HPLC method for simultaneous determination of ciprofloxacin hydrochloride and hydrocortisone in Compound Ciprofloxacin Ear Drops. Methods: ODS was used as the stationary phase. Methanol-acetonitrile 0.05 mol·L-1 citric acid solution (triethylamine adjusted to pH 3.5) (60:7:33) was used as the mobile phase. The detection wavelength was 245 nm. Results: The method of simultaneous determination of two components. Ciprofloxacin Hydrochloride and hydrocortisone in the 125 ~ 750μg · ml-1 and 12.5 ~ 75μg · ml-1 concentration range, the peak area and its concentration showed a good linear relationship, the average recovery and RSD were 100.15% , 0.37%; 100.16%, 0.47%. Conclusion: This method is simple, rapid, accurate and suitable for the quality analysis of the preparation.