应用LC-ESI-FTICRMS/MS^n技术研究吗替麦考酚酯原料药中有关物质  

Determination of related impurities in the mycophenolate mofetil bulk drug by LC-ESI-FTICRMS/MS^n

作　　者：王鹏远[1] 童元峰[1] 张金兰[1] 吴彩胜[1] 吴松[1] 

机构地区：[1]北京协和医学院中国医学科学院药物研究所,北京100050

出　　处：《中国新药杂志》2011年第1期54-59,74,共7页Chinese Journal of New Drugs

基　　金：国家卫生行业科研专项(200802038)

摘　　要：目的:分离鉴定吗替麦考酚酯(MMF)原料药中的有关物质。方法:采用液相色谱-电喷雾-傅立叶变换离子回旋共振质谱(LC-ESI-FTICRMS/MSn)技术对MMF原料药进行分析,获得主成分及有关物质的高分辨质谱数据(HRMS)和多级质谱数据(MSn),并对有关物质结构进行推断。结果:结合文献数据和质谱裂解规律,从MMF原料药中初步鉴定出6种有关物质。结论:在初步鉴定出的6种有关物质中,有3种与欧洲药典和美国药典收载的杂质相同,还有3种不同,说明同一原料药在不同生产工艺和环境条件下所产生的有关物质不尽相同,因此亟需建立符合我国实际情况的药品质量安全标准。Objective： To separate and identify the related impurities in mycophenolate mofetil（MMF） bulk drug.Methods： Liquid chromatography-electrospray ionization-Fourier transform ion cyclotron resonance mass spectrometry/multiple stages mass spectrometry（LC-ESI-FTICRMS/MSn） technique was used to obtain the HRMS and MSn data of the related impurities in MMF bulk drug.Results： Six related impurities were tentatively identified from MMF bulk drug on the basis of the HRMS,MSn,mass fragmentation mechanism and reference data.Conclusion： Six related impurities have been detected,and three of them have been collected in the European Pharmacopoeia and U.S.Pharmacopoeia while the others not.It means that the related impurities in the same bulk drug maybe different due to different production processes and environmental conditions.The quality and safety standards should be improved according to the bulk drug in our country.

关 键 词：吗替麦考酚酯 傅立叶变换离子回旋共振质谱 有关物质 结构鉴定 

分 类 号：R917[医药卫生—药物分析学] R979.5[医药卫生—药学]