基于高效液相色谱-高分辨串联质谱的他克莫司软膏杂质谱研究
Impurity Profile Study of Tacrolimus Ointment Based on High Performance Liquid Chromatography-High Resolution Mass Spectrometry
布仁 1周刚 2盛华 1莲花 1曹慧敏 3朱召贞 3白文明1
作者信息
- 1. 内蒙古医科大学药学院,呼和浩特 010110
- 2. 内蒙古自治区药品检验研究院,呼和浩特 010020
- 3. 山东瑞安药业有限公司,济南 250013
- 折叠
摘要
目的 研究他克莫司软膏的杂质谱,为仿制药质量标准制定提供依据.方法 采用高效液相色谱-高分辨串联质谱联用技术分析强制破坏后的他克莫司软膏杂质,根据一级、二级质谱数据结合杂质的质谱裂解方式,推测各杂质的来源和分子结构.结果 他克莫司软膏强制破坏后,共产生10个杂质,其中包括3组同分异构体.结论 本研究建立的杂质谱分析方法为他克莫司软膏的质量控制和工艺优化提供了参考依据.
Abstract
OBJECTIVE To investigate the impurity profile of tacrolimus ointment and lay a foundation for the establishment of generic drug quality standard.METHODS HPLC-HRMS/MS was adopted to analyze the impurities in destroyed tacrolimus ointment.According to the primary and secondary mass spectrometry data combined with the mass spectrometry fragmentation pat-terns of impurities,the source and molecular structures of the impurities were speculated.RESULTS Tacrolimus ointment to-tally produced 10 impurities after destructive test,wherein contained three groups of isomers.CONCLUSION The analysis method of impurity profile established in this study provides a reference basis for the quality control and process optimization of ta-crolimus ointment.
关键词
他克莫司软膏/杂质谱/裂解方式/高效液相色谱-高分辨串联色谱Key words
tacrolimus ointment/impurity profile/fragmentation pattern/HPLC-HRMS/MS引用本文复制引用
基金项目
内蒙古自治区自然科学基金面上项目资助(2020MS08045)
内蒙古医科大学面上项目资助(YKD2021MS022)
内蒙古医科大学他克莫司软膏补发试验资助(RH1900003513)
出版年
2024
NETL
NSTL
万方数据