Determination of potential genotoxic impurities in baritinib by GC
10.19778/j.chp.2025.02.017
- VernacularTitle:GC法测定巴瑞替尼原料药中潜在基因毒性杂质
- Author:
Zhao LI
1
;
Gang LONG
;
Wen LAN
;
Jinfeng ZHENG
;
Yanming LIU
;
Xiaoyi SHI
Author Information
1. 湖南省药品检验检测研究院,长沙 410001;国家药品监督管理局药用辅料工程技术研究重点实验室,长沙 410001
- Publication Type:Journal Article
- Keywords:
baritinib;
genotoxic impurity;
methyl ethanesulfonate;
ethyl ethanesulfonate;
isopropyl ethanesulfonate;
GC
- From:
Drug Standards of China
2025;26(2):232-236
- CountryChina
- Language:Chinese
-
Abstract:
Objective:A GC method was established for the determination of three potential genotoxic impuri-ties methyl ethanesulfonate,ethyl ethanesulfonate and isopropyl ethanesulfonate in baritinib raw materials.Methods:The chromatography was performed on Agilent J&W DB-1701(30 m×0.25 mm,1.0 μm)col-umn.The heating procedure was the initial temperature of 100℃,maintained for 3 min,at the rate of 5℃per minute to 180℃,maintained for 2 min,and then at the rate of 30℃per minute to 240℃,maintained for 5 min.The temperature of the injector was 240℃.The shunt ratio was 1∶10.The carrier gas was helium with a flow rate of 2.0 mL per minute.The temperature of the detector was 260℃and the injection volume was 2 μL.Results:The specificity,linearity and range,limit of quantification and detection,accuracy,pre-cision,repeatability and stability of the method meet the requirements.Conclusion:The analytical method is simple,accurate,sensitive and reproducible,and can be used for quality control of three potential genotoxic impurities in baritinib.
