摘要
大环内酯类抗生素是临床上常用的一类广谱抗感染药物。该类抗生素的组分通常比较复杂,故从用药安全和工艺控制方面,迫切需要建立该类抗生素的杂质谱。在痕量杂质的定性鉴别方面,串联质谱具有灵敏、快速等突出优势,故在杂质谱的建立方面应用越来越广。本文综述了采用串联质谱法解析大环内酯类抗生素中共存组分的思路以及该类化合物的质谱裂解规律,并以乙酰螺旋霉素杂质谱的建立为例,详细阐述了如何采用已知组分的解析规律定性解析未知组分的思路,以期对药物杂质谱的建立起有益提示。
Macrolide antibiotics are broad-spectrum, with activity against a range of Gram-positive, Gram- negative organisms and some anaerobes. The components of macrolide antibiotics are generally complicated. Therefore, it is very important to establish impurity profiles of these antibiotics to ensure their safety and process control. Compared with classical methods, the liquid chromatography-mass spectrometry method is particularly advantageous to characterize minor components at trace levels in terms of sensitivity, efficiency and selectivity, thus more and more widely used in establishments of impurity profiles. In this study, the general approaches to characterize minor components in complex pharmaceutical matrix, fragmentation pathways of 14- and 16- membered macrolide antibiotics and the establishment of the impurity profile of acetylspiramycin were given to provide valuable enlightenments to establish the impurity profiles of pharmaceutical products.
出处
《药学学报》
CAS
CSCD
北大核心
2013年第5期642-647,共6页
Acta Pharmaceutica Sinica
基金
科技部"重大新药创制"项目(2011ZX09303-001)
关键词
液相串联质谱
大环内酯类抗生素
杂质谱
liquid chromatography-mass spectrometry
macrolide antibiotics
impurity profile
