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目的对头孢拉定二水合物的杂质谱进行研究。方法应用柱切换技术和液质联用技术(LC-MS)对头孢拉定二水合物中的杂质峰进行鉴别,并通过强力实验,归纳各个杂质峰的来源。结果建立的头孢拉定二水合物的杂质谱包含14种杂质,其中9种杂质为《欧洲药典》控制的结构已知杂质;2种为新鉴定的杂质;3种为未知结构杂质。结论通过对头孢拉定二水合物杂质谱的研究,分析了杂质的来源及其影响因素,为质量控制提供了参考。
Objective To study the impurity spectrum of cefradine dihydrate. Methods The impurity peaks of cefradine dihydrate were identified by column-switching technique and liquid chromatography-mass spectrometry (LC-MS), and the sources of various impurity peaks were summarized by intensive experiments. Results The impurity spectrum of cefradine dihydrate contained 14 kinds of impurities, among which 9 kinds of impurities were known structures controlled by the European Pharmacopoeia, 2 kinds were newly identified impurities and 3 kinds were unknown structure impurities. Conclusion The study of the impurity spectrum of cefradine dihydrate shows that the source of impurities and its influencing factors provide a reference for quality control.