聚苯乙烯凝胶色谱柱分离头孢呋辛钠聚合物杂质

Separation of Polymer Impurities in Cefuroxime Sodium by Polystyrene-based Gel Filtration Chromatography

建立了聚苯乙烯基质的凝胶色谱柱系统对头孢呋辛钠中聚合物杂质(或称缩合物杂质)的分离分析方法。凝胶色谱柱为MKF-GPC-100柱(100 mm×7.8 mm,5μm),流动相为0.01 mol/L的磷酸盐缓冲液(pH7.0)-乙腈(70∶30,体积比),流速1.0 mL/min,检测波长254 nm。头孢呋辛钠与其缩合物杂质实现了较好的分离,分析周期耗时在10 min以内。该方法可以迅速、简便地用于头孢呋辛钠缩合物杂质的分离分析。

A polystyrene-based gel filtration chromatographic method was established for the isolation and examination of condensation impurity in cefuroxime sodium. The sample was separated with MKF-GPC-100（100 mm ×7.8 mm, 5 μm） column uisng 0. 01 mol/L phosphate buffer（pH 7.0） - acetonitrile（70 ： 30, by volume） as mobile phase. The flow rate was set at 1.0 mL/min and the detecting wavelength was set at 254 nm. The result indicated that the cefuroxime sodium was successfully separated from condensation impurity in 10 rain. The method showed the advantages of simplicity and rapidness.