高效液相色谱法检查巴洛沙星原料及片剂中有关物质

HPLC determination of related substances in balofloxacin and tablets

目的建立测定巴洛沙星原料及片剂中有关物质的高效液相色谱法。方法采用C18色谱柱(250×4.6mm,5μm);以0.05mol/L枸椽酸-乙腈(80∶20,用三乙胺调pH值为7.5)为流动相;检测波长264nm。结果巴洛沙星与其它杂质峰完全分离,从而对其有关物质进行限量检查。结论该法操作简便,结果准确,影响因素少。

OBJECTIVE To establish an HPLC method for determination of related substances in balofloxacin material and tablets. METHODS A C18 column（5μm,4.6 × 250mm） was used with the mobile phase of 0.05mol/L citric acid-acetonitrile（ 80：20 adjust pH to 7.5 with triethylamine）, the detection wavelength was 264nm. RESULTS Balofloxacin was separated from the related substances completely and the limit of the main impurity was analyzed. CONCLUSION The method is rapid, simple and accurate.