在线二维凝胶色谱反相液相色谱-飞行时间质谱技术对盐酸头孢替安中聚合物杂质的分析研究

发布时间：2017-12-27 23:02

本文关键词：在线二维凝胶色谱反相液相色谱-飞行时间质谱技术对盐酸头孢替安中聚合物杂质的分析研究　出处：《中国药学杂志》2016年09期 　论文类型：期刊论文

【摘要】：目的对β-内酰胺类抗生素中聚合物杂质检测的常规凝胶色谱方法进行有效性考察,并且实现凝胶色谱法与反相高效液相系统有关物质分析方法的有效统一。方法采用在线二维柱切换技术和液质联用技术对常规凝胶色谱法的有效性进行考察,同时将凝胶色谱检出的杂质在反相液相色谱系统中进行定位及结构推断。结果常规凝胶色谱法检测的盐酸头孢替安中的聚合物杂质主要为降解物杂质及开环物杂质等,无法有效的表征致敏性聚合物杂质。结论在线柱切换技术可以有效地将凝胶色谱法的优势与指针性聚合物杂质的定位结合起来,为建立真实有效的表征聚合物杂质的研究思路奠定基础。
[Abstract]:Objective to investigate the effectiveness of conventional gel chromatography for the detection of polymer impurities in beta lactam antibiotics, and to achieve effective unification of gel chromatography and related substances analysis methods in RP HPLC system. Methods online two-dimensional column switching and liquid chromatography-mass spectrometry were used to investigate the effectiveness of conventional gel chromatography. Meanwhile, the location and structure of impurities detected by gel chromatography were analyzed in RP HPLC system. Detection results of conventional gel chromatography of cefotetan polymer impurity mainly for the degradation of Anzhong impurities and open loop impurities, can not be effective characterization of sensitized polymer impurity. Conclusion online column switching technology can effectively combine the advantages of gel chromatography with the location of pointer polymer impurities, and lay the foundation for establishing a real effective way to characterize polymer impurities.
【作者单位】：上海市食品药品检验所;复旦大学化学系;
【分类号】：R917;O657.63
【正文快照】： 系,上海200433)盐酸头孢替安为半合成的第二代头孢菌素,如同其他β-内酰胺类抗生素,其具有引发不同类型的过敏反应的潜在危险。文献[1-2]表明,药物中存在的高分子聚合物是引发β-内酰胺类抗生素过敏反应的一个重要的过敏原。严格控制β-内酰胺类抗生素中聚合物杂质的量是提高

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