左奥硝唑氯化钠注射液中杂质的分离、结构鉴定及构型分析

目的 对左奥硝唑氯化钠注射液中的主要杂质进行结构分析.方法 采用高效液相色谱-四级杆/飞行时间质谱联用(HPLC-QTOF-MS)技术对其中最大杂质进行解析推断,再利用制备高效液相色谱仪从左旋奥硝唑氯化钠注射液中分离制备目标物质,并通过核磁技术进行结构确证.结果 确证了左奥硝唑氯化钠注射液的1个主要杂质的结构为S-(-)-3-(2-甲基-5-硝基咪唑)-1,2-丙二醇,是左奥硝唑氯化钠注射液高温灭菌过程中产生的降解产物.结论 本研究为左奥硝唑氯化钠注射液的杂质分析、质量控制提供依据.

Isolation and structure identification of major impurity in levornidazole and sodium chloride injection

Objective To identify the structure of the major impurity in levornidazole and sodium chloride injection.Methods HPLC-Q-TOF-MS was adopted to analyze the structure of the impurities. The major impurity was further separated and prepared by prep-HPLC and the structure was elucidated by NMR spectral data. Results The chemical structure of the major impurity in levornidazole and sodium chloride injection was elucidated as S-( -)-3-( 2-methyl-5-nitro-1H-imidazole )-1, 2-propanediol, which was the outcome of thermo-degradation impurity during heat sterilization. Conclusion This study provides reference for analyzing the impurities and quality control of levornidazole and sodium chloride injection.