HPLC法同时测定复方环丙沙星滴耳液中2种组分的含量

Simultaneous Determination of Two Constituemts in Compound Ciprofloxacin Ear Drops by HPLC

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 a method for determination of ciprofloxacin hydrochloride and hydrocortisone in compound ciprofloxacin ear drops. Method: ODS as stationary phase,methanol-acetonitrile-(0.05) mol· L^(-1) citric acid in water(adjusted to pH (3.5) with triethylamine)(60∶7∶33) as mobile phase, the wavelength of detection was at 245 nm. Result: The separation and determination of two constituents could be accomplished simultaneously. The calibration curves were linear within the ranges of 125-750 μg·ml^(-1) for ciprofloxacin hydrochloride and (12.5)-75 μg·ml^(-1) for hydrocortisone. The average recoveries of ciprofloxacin hydrochloride and hydrocortisone were (100.15%) (RSD=(0.37%)) and (100.16%) (RSD=(0.47%)), respectively. Conclusion: The method is simple, rapid, and accurate, and can be used for quanlity analysis of this preparation.