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反相高效液相色谱法测定普卢利沙星中的有关物质
引用本文:刘利军. 反相高效液相色谱法测定普卢利沙星中的有关物质[J]. 中南药学, 2010, 8(6): 423-425
作者姓名:刘利军
作者单位:湖南省药品检验所,长沙,410001
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。

关 键 词:反相高效液相色谱法  普卢利沙星  有关物质

Determination of relevant substances in prulifloxacin by RP-HPLC
LIU Li-jun. Determination of relevant substances in prulifloxacin by RP-HPLC[J]. Central South Pharmacy, 2010, 8(6): 423-425
Authors:LIU Li-jun
Affiliation:LIU Li-jun(Hunan Institute of Drug Control,Changsha 410001)
Abstract: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.
Keywords:RP-HPLC prulifloxacin relevant substance
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