阿昔洛韦片有关物质的LC-Q-TOF/MS鉴定  

Identification of the related substances in aciclovir tablets by LC-Q-TOF/MS

作　　者：王李杰 林冬香 朱米群 陆宇婷 宋敏[1] 杭太俊[1] WANG Li-jie;LIN Dong-xiang;ZHU Mi-qun;LU Yu-ting;SONG Min;HANG Tai-jun(Department of Pharmaceutical Analysis,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国药科大学药物分析系,南京210009

出　　处：《药物分析杂志》2023年第8期1381-1393,共13页Chinese Journal of Pharmaceutical Analysis

基　　金：国家药品监督管理局化学药品杂质谱研究重点实验室开放课题(No.NMPA-KLIPCD-2020-03)。

摘　　要：目的:阿昔洛韦片有关物质的LC-Q-TOF/MS鉴定。方法:采用ODS(250 mm×4.6 mm,5μm)色谱柱,以0.15%甲酸10 mmol·L^(-1)甲酸铵缓冲液-乙腈为流动相梯度洗脱,对阿昔洛韦片有关物质进行分离,采用电喷雾正离子化-四极杆-飞行时间串联质谱高分辨测定各有关物质母离子及其子离子的准确质量和元素组成,并解析鉴定其结构。结果:在所建立的LC-Q-TOF/MS分析条件下,阿昔洛韦及其有关物质分离良好,检测并鉴定出阿昔洛韦片及其强制降解试验样品中包括欧洲药典规定的7个已知杂质在内的23个主要有关物质。结论:研究结果可为阿昔洛韦片质量控制提供参考。Objective:To identify the related substances in aciclovir tablets by LC-Q-TOF/MS.Methods:The separation of the related substances in aciclovir tablets were carried out on an ODS(250 mm×4.6 mm,5μm)column with gradient elution using 0.15%formic acid 10 mmol·L^(-1)ammonium formate buffer solution and acetonitrile as mobile phases.The accurate mass and elemental composition of the parent ions and their product i⁃ons of the related substances were determined by electrospray-ionization quadrupole time-of-flight high resolu⁃tion mass spectrometry.The structures of the related substances were elucidated.Results:Under the established LC-Q-TOF/MS condition,aciclovir and its related substances were adequately separated,and 23 major related substances including 7 known impurities specified in the EP were detected and identified in aciclovir tablets and its stressed samples.Conclusion:The results can provide reference for the quality control of aciclovir tablets.

关 键 词：阿昔洛韦片 有关物质 结构鉴定 强制降解 LC-Q-TOF/MS 

分 类 号：R917[医药卫生—药物分析学]