程玉宝,杨伟涵,张莉,黎其荣
CHENG Yubao,YANG Weihan,ZHANG Li,LI Qirong

• 1:珠海联邦制药股份有限公司

摘要(Abstract)：

目的建立液相色谱-质谱法快速分析多立培南在酸性条件下的降解产物。方法借助高效液相色谱-单四级杆质谱仪测定多立培南的酸降解产物,并根据质谱所获得降解产物相对分子质量信息,结合反应机制及相关文献推测降解产物结构。结果多立培南与酸降解产物能有效分离,3个主要降解产物分别为多立培南开环物、开环二聚物、闭环二聚物。结论该方法快速、灵敏、专属性强,能够有效控制多立培南的质量,并且对多立培南聚合物可以进行准确监控。
OBJECTIVE To establish a rapid LC-MS analytical method for determination of the doripenem acid degradation impurities. METHODS The acid degradation compounds of doripenem were determined by means of high performance liquid chromatography-single quadrupole mass spectrometer,and their structures were inferred according to their molecular mass and reaction mechanism. RESULTS Doripenen and its acid degradation impurities could be effectively separated,open-ring doripenem,open-ring doripenem dimer,and closed-ring doripenem dimer were proved to be doripenem acid degradation impurities. CONCLUSION The established method was rapid and reliable,with good specificity,it can be used for the quality control of doripenem,and can be monitored doripenem dimer accurately.

关键词(KeyWords)： 多立培南;液相色谱-质谱法;降解产物
doripenem;LC-MS analytical method;degradation impurities

Abstract:

Keywords:

基金项目(Foundation): 广东省教育部产学研结合示范基地项目(2010B091101010)

作者(Author): 程玉宝,杨伟涵,张莉,黎其荣
CHENG Yubao,YANG Weihan,ZHANG Li,LI Qirong

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