摘要
为了研究尼麦角林及其制剂中的有关物质,采用电喷雾正离子化-飞行时间质谱法(ESI-TOF/MS)测定各有关物质的准确质量,三重四极质谱(ESI-MS/MS)测定子离子特征。根据对照品比对、质谱裂解分析,结合合成工艺与强制降解实验,检测并鉴定了尼麦角林及其制剂中的16个主要有关物质(8个合成副产物、8个降解产物),为尼麦角林生产工艺控制和质量保障提供参考依据。
To study the related substances in nicergoline, electrospray positive ionization high resolution TOF/MS was used for the determination of the accurate mass and elemental composition of the related substances. Triple quadrupoles tandem MS/MS was employed for the determination of the fragmentations of the parent ions. 16 related substances were detected and identified to be eight synthetic by-products and eight degradation products, by using impurity references matching, product mass spectra fragmentations elucidation, and verified further according to synthetic processes and stress testing results. The results obtained are valuable for nicergoline manufacturing process control and quality assurance.
出处
《药学学报》
CAS
CSCD
北大核心
2015年第8期1026-1031,共6页
Acta Pharmaceutica Sinica
基金
2013国家药品计划抽验(中央补助地方经费项目)品种28号
