1. 南京工业大学生物与制药工程学院色谱中心
2. 江苏省药品检验所
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倪静文, 魏荣卿, 刘晓宁, 等. 聚苯乙烯凝胶色谱柱分离头孢呋辛钠聚合物杂质[J]. 分析测试学报, 2011,30(1):1-5.
Separation of Polymer Impurities in Cefuroxime Sodium by Polystyrene based Gel Filtration Chromatography[J]. 2011,30(1):1-5.
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×78 mm,5 μm),流动相为001 mol/L的磷酸盐缓冲液(pH 70)-乙腈(70∶30,体积比),流速10 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×78 mm,5 μm) column uisng 001 mol/L phosphate buffer(pH 70)-acetonitrile(70∶30,by volume) as mobile phase.The flow rate was set at 10 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 min.The method showed the advantages of simplicity and rapidness.
聚苯乙烯凝胶MKF GPC 100头孢呋辛钠缩合物杂质
polystyrene gelMKF GPC 100cefuroxime sodiumcondensation impurity
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