摘要
为探索一种利用质谱快速鉴定血管紧张素Ⅱ受体拮抗药中未知杂质结构的方法,采用电子轰击质谱(EI-MS)和电喷雾串联质谱(ESI-MS/MS)研究已上市的6种沙坦类药物。通过解析碎片离子并结合高分辨质谱确证裂解途径,总结沙坦类药物的质谱裂解规律,并将其应用于未知杂质结构的快速鉴定。据此鉴定了阿齐沙坦原料药中的2个未知的同分异构体杂质,杂质1为噁二唑环的氮原子被乙基化,杂质2为阿齐沙坦羧酸乙酯。
Six listed sartan drugs were studied by electron impact ionization-mass spectrometry （EI-MS） and electrospray ionization-tandem mass spectrometry （ESI-MS/MS） in order to explore a rapid method for the identification of unknown impurities in angiotensin II receptor blockers. Through the analysis of the main fragment ions and the data of high resolution mass spectrometry, fragmentation patterns and regularities were summarized and utilized in the rapid identification of unknown impurities. The structures of two unknown enantiomeric impurities in azilsartan were identified based on the above findings, impurity 1 was the ethylated product on nitrogen of oxadizole and impurity 2 was the ethyl ester of azilsartan.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2017年第1期68-77,共10页
Chinese Journal of Pharmaceuticals
关键词
沙坦类药物
电子轰击电离
电喷雾电离
质谱
裂解规律
结构鉴定
sartans
electron impact ionization
electrospray ionization
mass spectrometry
fragmentation regularity
structure identification
