HPLC测定普卢利沙星胶囊的含量和有关物质

 目的采用高效液相色谱法测定普卢利沙星胶囊的含量及有关物质。方法采用Waters Symmetry C₁₈色谱柱(4.6 mm×250 mm,5μm);以0.1%三乙胺水溶液(用10%磷酸调节pH为2.8)-乙腈(67.5∶32.5)为流动相;流速1.0 mL·min^-1;柱温25℃;波长275 nm;进样量10μL。结果含量测定的线性范围为0.50～10.00 mg·L^-1,r=0.999 3(n=5),低、中、高3个浓度加样回收率为101.2%,99.8%,98.2%;RSD依次为1.2%,0.9%,0.4%(n=5)。结论本方法简便快速、准确,专属性好。

Determination of Prulifloxacin and Its Related Substances in Capsules by HPLC

OBJECTIVE To establish a HPLC-UV method for the determination of prulifloxacin and its related sustances in capsules.METHODS Using a Waters symmatry C₁₈ column(4.6 mm×250 mm,5 μm).The mobile phase consisted of 0.1% triethylamine(pH was adjusted to 2.8 using phosphoric acid)-acetomitrile(67.5∶32.5).The flow rate was 1.0 mL·min^-1 with UV detection at 275 nm.The column temperature was 25 ℃.The injection volume was 10 μL.RESULTS The linear range for the content of prulifloxacin was 0.50～10.00 mg·L^-1(r=0.999 3,n=5). The recoveries of prulifloxacin capsules were 101.2%,99.8%,98.2% and its RSDs were 1.2%,0.9% and 0.4%(n=5).CONCLUSION The method is sample,rapid,accurate and is suitable for the determination of prulifoxacin and its related substances.