| 引用本文: | 何劼毅,聂鹏,黄春青.盐酸环丙沙星中氯代环丙沙星的质量控制[J].中国现代应用药学,2022,39(19):2538-2542. |
| HE Jieyi,NIE Peng,HUANG Chunqing.Quality Control of Chlorociprofloxacin in Ciprofloxacin Hydrochloride[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(19):2538-2542. |
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| 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。 |
| 关键词: 盐酸环丙沙星 氯代环丙沙星 质量控制 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.19.016 |
| 分类号:R971.101 |
| 基金项目:贵州省科技计划项目(黔科合基础-ZK[2021]一般041) |
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| Quality Control of Chlorociprofloxacin in Ciprofloxacin Hydrochloride |
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HE Jieyi, NIE Peng, HUANG Chunqing
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Guizhou Institute for Food and Drug Control, Guiyang 550008, China
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| 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. |
| Key words: ciprofloxacin hydrochloride chlorociprofloxacin quality control |
