中国医药科学2024，Vol.14Issue(7)：68-72,5.DOI:10.20116/j.issn2095-0616.2024.07.16
LC-HRMS/MS研究富马酸替诺福韦二吡呋酯片中聚合物
LC-HRMS/MS study on polymers in tenofovir disoproxil fumarate tablets
摘要
Abstract
Objective To study the potential polymer impurities in tenofovir disoproxil fumarate tablets.Methods The samples rich in impurities(including the samples after the destructive experiment)were studied by liquid chromatography-mass spectrometry(LC-MS)with atmospheric pressure chemical ionization source(APCI ion source)and electrospray ionization source(ESI ion source),with their potential polymers found and their structures speculated.Results Dimer and trimer impurities were detected in the sample after the destructive experiment of tenofovir disoproxil fumarate tablets.Conclusion There are potential detectable polymer impurities in tenofovir disoproxil fumarate tablets:dimer and trimer impurities,among which the three impurities in the dimer are known impurities,namely H,W,and S.关键词
富马酸替诺福韦二吡呋酯/二聚体/三聚体/液质联用Key words
Tenofovir disoproxil fumarate/Dimer/Trimer/Liquid chromatography-mass spectrometry分类
医药卫生引用本文复制引用
肖颖,王健松,袁晓,林顺权,叶心睿..LC-HRMS/MS研究富马酸替诺福韦二吡呋酯片中聚合物[J].中国医药科学,2024,14(7):68-72,5.基金项目
广东省广州市知识产权工作专项资金(ZL201710649577.9). （ZL201710649577.9）
