关于中国药典2000年版中头孢呋辛酯相关物质检查限度的商讨
头孢呋辛酯,,头孢呋辛酯；相关物质；HPLC梯度洗脱法；药物分析,1实验部分,2实验方法与结果,3讨论,参考文献
摘 要 采用HPLC梯度洗脱法(C18柱，5 μm，150 mm×4.6 mm)检查头孢呋辛酯中的各杂质，并对杂质的限度和计算方法进行了讨论，认为应对头孢呋辛酯中各已知杂质和总杂质分别控制，并采用自身对照法代替CHP2000年版中简单的面积比较法较为合理。关键词 头孢呋辛酯；相关物质；HPLC梯度洗脱法；药物分析
A Probe on the Detection Limits of Relative Impurities in Cefuroxime Axetil Reported in Chinese Pharmacopia 2000
Abstract Impurities in cefuroxime axetil were detected with HPLC gradient elution (C18 column, 5μm, 150 mm×4.6 mm). Impurity limits and their calculation methods were also discussed. It is concluded that known impurities and total impurity should be controlled separately, and application of the alterative self-control method seems more rational than the simple area comparison method recommended in Chinese Pharmacopia 2000 (CHP2000).
Key words cefuroxime axetil, relative impurity, HPLC gradient elution
头孢呋辛酯是头孢呋辛的酯类前体药物 ......
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