【摘要】 目的 采用高效液相色谱法建立普卢利沙星片有关物质检查及其含量测定方法。方法 Diamonsil-C18柱(4.6mm×200mm, 5μm)，以0.01mol/L三乙胺的水溶液(用磷酸调节pH为2.8)-乙腈(73：27)为流动相；检测波长278nm；流速1.0ml/min；柱温30℃；进样量10μl。结果 制剂中辅料对主药测定无干扰，普卢利沙星与有关物质完全分离。在10.0～200.0μg/ml范围内峰面积与浓度呈良好的线性关系。精密度(RSD=0.13%)良好。平均回收率为99.6%。结论 本方法简便，迅速，准确，专属性强。

    【关键词】 普卢利沙星；片剂；高效液相色谱法；含量测定；有关物质

    Determination of prulifloxacin and its related substances in tablets by HPLC

    WANG Qi,LI Zhi-feng,XU Yan-li,et al.

    Department of Pharmacy,Qingan People's Hospital,Qingan 152400，China

    【Abstract】 Objective To establish an HPLC-UV method for the determination of prulifloxacin and its related substances in tablets. Methods Diamonsil-C18 column (4.6mm×200mm, 5μm) was used. The mobile phase is consisted of 0.01mol/L triethylamine (pH was adjusted to 2.8 using phosphoric acid)-acetonitrile (73∶27). The flow rate was 1.0 ml/min with UV detection at 278nm. The column temperature was 30℃. The injection volume was 10μl.Results The linear range for the content of prulifloxacin was 10.0～200.0μg/ml (r=0.9999 3 ......