盐酸环丙沙星中氯代环丙沙星的质量控制

Quality Control of Chlorociprofloxacin in Ciprofloxacin Hydrochloride

摘要: 目的建立以高效液相色谱法测定盐酸环丙沙星中氯代环丙沙星含量的方法。方法采用Welch Ultimate Plus C₁₈色谱柱(4.6 mm×250 mm，5 μm)，梯度洗脱，流速为1.5 mL·min^–1，检测波长278 nm。结果氯代环丙沙星和环丙沙星以及其他杂质分离度良好，氯代环丙沙星在1.050~10.5 μg·mL^–1内线性良好(r=0.999 9)，回收率为108.8%(RSD=1.97%)。结论建立的质量标准简便、快捷、专属性强，可以更好地控制盐酸环丙沙星的质量。

Abstract: OBJECTIVE To establish an HPLC method for determination of chlorociprofloxacin in ciprofloxacin hydrochloride.METHODS The analysis was performed on a Welch Ultimate Plus C₁₈ column (4.6 mm×250 mm,5 μm) with gradient elution.The flow rate was 1.5 mL·min^–1,and the detection wavelength was 278 nm.RESULTS The other impurities and ciprofloxacin was completely separated from chlorociprofloxacin.Chlorociprofloxacin revealed good linearity over the range of 1.050–10.5 μg·mL^–1(r=0.999 9),and the average recovery was 108.8%,while the RSD was 1.97%.CONCLUSION The method is rapid,accurate,sensitive,and can be well control the quality of ciprofloxacin hydrochloride.