Profiling of genotoxic impurities in a lidocaine hydrochloride injection
10.11665/j.issn.1000-5048.20200412
- VernacularTitle:盐酸利多卡因注射剂遗传毒性杂质研究
- Author:
Zhiran XIAN
1
;
Chunmeng SUN
;
Xuefang LUO
;
Wenying ZHONG
Author Information
1. 中国药科大学理学院药物质量研究中心
- Publication Type:Journal Article
- Keywords:
Lidocaine hydrochloride injection;
genotoxic impurities;
LC-MS/MS
- From:
Journal of China Pharmaceutical University
2020;51(4):467-473
- CountryChina
- Language:Chinese
-
Abstract:
2,6-dimethylbenzenamine was determined as a genotoxic impurity in lidocaine hydrochloride injection, and 2-chloro-N-(2,6- dimethylphenyl) acetamide was determined as potential genotoxic impurity. An LC-MS/MS method was established to research the profiling of genotoxic impurities in active pharmaceutical ingredients (API), homemade preparation and reference preparation on column Agilent ZORBAX Eclipse Plus C18(4.6 mm250 mm，5 μm). The results show that in the homemade preparation the 2,6-dimethylbenzenamine and the 2-chloro-N-(2,6-dimethylphenyl) acetamide may be degraded under oxidation condition and alkaline condition in addition to the introduction from API preparation process. This study provides guidance for genotoxic risk assessment and prescription process optimization of lidocaine hydrochloride.
