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目的:采用高效液相色谱法测定盐酸洛美沙星胶囊中盐酸洛美沙星的含量及其有关物质。方法:用Lichospher ODS- C_(18)柱(250 mm×4.6 mm,5μm);以0.05 mol·L~(-1)枸橼酸溶液(用三乙胺调节pH至4.0)-乙腈(87:13)为流动相;检测波长287 nm。结果:盐酸洛美沙星的线性范围为20～200μg·ml~(-1)(r=0.9995),平均回收率为99.7%(n=9)。结论:方法重复性好,准确度高,适于盐酸洛美沙星胶囊的质量控制。
Objective: To determine the content of lomefloxacin hydrochloride and its related substances in lomefloxacin hydrochloride capsules by high performance liquid chromatography. METHODS: The cells were stained with Lichospher ODS-C 18 column (250 mm × 4.6 mm, 5 μm), citric acid solution (adjusted to pH 4.0 with triethylamine) -acetonitrile (87: 13) as mobile phase; detection wavelength 287 nm. Results: The linear range of lomefloxacin hydrochloride was 20 ~ 200μg · ml ~ (-1) (r = 0.9995). The average recovery was 99.7% (n = 9). Conclusion: The method is reproducible and accurate. It is suitable for the quality control of Lomefloxacin Hydrochloride Capsules.