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

目的研究富马酸替诺福韦二吡呋酯片中潜在的聚合物杂质。方法采用液质联用方法,选用大气压化学离子化源(APCI离子源)和电喷雾离子化源(ESI离子源)对富含杂质的样品(包括破坏实验后的样品)进行聚合物研究,发现其潜在的聚合物并推测其结构。结果富马酸替诺福韦二吡呋酯片破坏样品中检出二聚体、三聚体杂质。结论富马酸替诺福韦二吡呋酯片中存在潜在可检出的聚合物杂质:二聚体和三聚体杂质,其中二聚体的三个杂质为已知杂质,分别为杂质H、W、S。

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.