普卢利沙星胶囊的含量及有关物质的HPLC测定

Determination of Prulifloxacin and Related Substances in Its capsules by HPLC

建立了HPLC法测定普卢利沙星胶囊含量及有关物质。方法采用PICO·TAG TM C18色谱柱(5μm,3.9 mm×150 mm);以乙腈-水-十二烷基硫酸钠(425:500:2.5,用磷酸调节pH为3.0)为流动相;流速1.0 mL/min;检测波长为275 nm;柱温:室温;进样量:20μL。结果普卢利沙星浓度在12～36μg/mL范围内具有良好的线性关系,r=0.9999(n=5);平均回收率为99.7%,RSD为0.3%。结论本方法简便、快速、准确,可作为普卢利沙星质量控制的方法。

A HPLC method for the determination of prulifloxacin and related substances in its capsules was established.The separation was performed on a PICO？TAG TM C18 column（5μm 3.9 mm×150 mm）.The mobile phase was composed of acetonitrile-water-sodium laury sulfate（425：500：2.5）,adjusted to pH3.0 with phosphoric acid.The flow rate was 1.0 mL/min.The detection was carried out with a UV detector at 275nm.The chromatography was conducted at room temperature,20μL were injected.The calibration curves were liners between 12～36 μg/mL（r=0.9999）.The average recovery was 99.7% with RSD of 0.297%.