奥硝唑氯化钠注射液主要杂质的结构鉴定
Characterization of major impurity in ornidazole and sodium chloride injection
分类号:
出版年·卷·期(页码):2012,32 (10):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------
目的: 对奥硝唑氯化钠注射液的主要杂质进行结构分析。 方法: 采用HPLC-QTOF-MS联用技术对该杂质进行鉴定;利用制备高效液相色谱从奥硝唑氯化钠注射液中分离制备该杂质,并进一步采用核磁技术进行结构确证。 结果: 确证了奥硝唑氯化钠注射液的1个主要杂质的结构。 结论: 本研究对奥硝唑氯化钠注射液的杂质分析、质量控制具有重要作用。
-----英文摘要:---------------------------------------------------------------------------------------
Objective: To identify the structure of the major impurity of ornidazole and sodium chloride injection. Methods: HPLC-QTOF-MS was adopted to analyze the structure of this impurity;the impurity was separated from ornidazole and sodium chloride injection by prep-HPLC,and its structure was further identified by NMR. Results: The chemical structure of the major impurity of ornidazole and sodium chloride injection was elucidated. Conclusion: The study offers scientific data for studying the impurities of ornidazole and sodium chloride injection and improving its quality.
-----参考文献:---------------------------------------------------------------------------------------
1 TIAN Huai-ping(田怀平),WANG Mei-na(王美纳).Pharmacological effects and clinical application of ornidazole(奥硝唑的药理作用及临床应用).China Pharm(中国药房),2003,14(1):50
2 Jokipii L,Jokipii AM.Comparative evaluation of the 2-methyl-5-nitroimidazole compounds dimetridazole,metronidazole,secnidazole,ornidazole,tinidazole,carnidazole,and panidazole against bacteroides fragilis and other bacteria of the bacteroides fragilis group.Antimicrob Agents Chemother,1985,28(4):561
3 National Drug Standards(国家药品标准).YBH02892004
4 WANG Duo-jiao(王多娇),SONG Min(宋敏),HANG Tai-jun(杭太俊),et al.Identification of related substances in olmesartan medoxomil by LC-MS/MS(液相色谱-质谱联用技术鉴定奥美沙坦酯有关物质).Chin J Pharm Anal(药物分析杂志),2012,32(1):82
5 National Drug Standards(国家药品标准).WS1-(X-454)-2003Z-2010
6 National Drug Standards(国家药品标准).WS1-(X-012)-2010Z-2010
7 CHEN Fa-gui(陈法贵),WU Hai-ying(吴海英),CHEN Hong-xiang(陈鸿翔),et al.Establishment of analytical method for determining the related substance of ornidazole(奥硝唑有关物质分析方法的建立).Chin J Pharm Anal(药物分析杂志),2004,24(3):267
8 Hoffer M,Grunberg E.Synthesis and antiprotozoal activity of 1-(3-Chloro-2-hydroxypropyl)-substituted nitroimidazoles.J Med Chem,1974,17(9):1019
9 JIA Fei(贾飞),LI Jue(李珏).Discussion on the impurity control of the determination of related substance in tinidazole and tinidazole injection(探讨替硝唑及其注射液有关物质中杂质的控制).Drug Stand China(中国药品标准),2009,10(5):341
10 LI Zhong-hong(李忠红),WANG Xiao-juan(汪晓娟),CAI Mei-ming(蔡美明),et al.Analysis of ornidazole's related substances by LC-ESI-MS(奥硝唑有关物质的液相色谱-电喷雾离子化-质谱联用分析).Drug Stand China(中国药品标准),2008,9(4):277
11 ChP(中国药典).2010.Vol Ⅱ(二部):Appendix(附录) XIX F
欢迎阅读《药物分析杂志》!您是该文第 1374位读者!