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。
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 patterns of impurities,the source and molecular structures of the impurities were speculated.RESULTS Tacrolimus ointment totally 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 tacrolimus ointment.
作者
布仁
周刚
盛华
莲花
曹慧敏
朱召贞
白文明
BU Ren;ZHOU Gang;SHENG Hua;LIAN Hua;CAO Huimin;ZHU Zhaozhen;BAI Wenming(College of Pharmacy,Inner Mongolia Medical University,Hohhot 010110,China;Inner Mongolia Institutes for Drug Control,Hohhot 010020,China;Shandong Ryan Pharmaceutical Co.,Ltd.,Jinan 250013,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2024年第1期78-87,共10页
Chinese Pharmaceutical Journal
基金
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)。
