天津师范大学学报（自然科学版）2025，Vol.45Issue(2)：18-24,7.DOI:10.19638/j.issn1671-1114.20250204
基于高效液相色谱-四极杆飞行时间质谱联用技术的依达拉奉注射液杂质谱分析
Analysis of impurity profile of edaravone injection by HPLC-Q-TOF-MS
摘要
Abstract
In order to understand the impurities in edaravone injection and optimize its production process,high performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry(HPLC-Q-TOF-MS)was used to identify the struc-ture of impurities in edaravone injection and its forced degradation experimental samples.The results showed that:① Edar-avone and its impurities were well separated by HPLC-Q-TOF-MS;② Eight major impurities were detected in edaravone in-jection and its forced degradation products,among which three impurities were the known impurities including impurity 4(edaravone impurity Ⅳ),impurity 6(edaravone impurity Ⅰ),and impurity 8(edaravone impurity Ⅲ);③ Edaravone was easily to be oxidized,and edaravone impurity Ⅰ and edaravone impurity Ⅲ were oxidative degradation impurities.关键词
依达拉奉注射液/杂质谱/强制降解/结构鉴定/高效液相色谱-四极杆飞行时间质谱Key words
edaravone injection/impurity profile/forced degradation/structural identification/high performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry(HPLC-Q-TOF-MS)分类
药学引用本文复制引用
贾文君,曹玉,戴震,邵冉薇,李玲..基于高效液相色谱-四极杆飞行时间质谱联用技术的依达拉奉注射液杂质谱分析[J].天津师范大学学报（自然科学版）,2025,45(2):18-24,7.基金项目
江苏省药品监督管理局2022年度药品监管科学研究计划项目(202240). （202240）
