摘要
目的建立反相高效液相色谱法测定普卢利沙星中的有关物质。方法采用VP-ODS C18(4.6 mm×150mm,5μm)色谱柱,以乙腈-稀磷酸(1→1 000)-1 mol.L-1戊烷磺酸钠溶液(27∶72∶1)为流动相,流速1.5mL.min-1,检测波长275 nm,柱温25℃。结果在本文色谱条件下普卢利沙星与相邻杂质峰的分离度>1.5,普卢利沙星、中间体(A、B、C)和杂质A均能完全分离。结论该方法简便、准确、可行,可用于普卢利沙星的质量控制。
Objective To establish a reversed phase high performance lipuid chromatography method for the determination of relevant substances in prulifloxacin.Methods VP-ODS C18 column（4.6 mm×150 mm,5 μm） was used,the mobile phase consisted of acetonitrile-dilute phosphoric acid（1→1 000）-1 mol·L^-1 n-pentane sulfonate solution（27∶72∶1） at 1.5 mL·min^-1,and the column temperature was 25 ℃.Results The separating size of prulifloxacin and its adjacent impurity chromatographic peak was more than 1.5.Prulifloxacin and intermediate（A,B,C） and impurity A were seperated well.Conclusion The method is simple,accurate and reproducible.It can be used to control the quality of prulifloxacin.
出处
《中南药学》
CAS
2010年第6期423-425,共3页
Central South Pharmacy
