注射用盐酸头孢唑兰中有关物质的分离与结构鉴定  

Isolation and structure identifi cation of related substances from cefozopran hydrochloride for injection

作　　者：陈钢[1] 余欢[1] 盛力[1] 

机构地区：[1]浙江医药股份有限公司新昌制药厂,新昌312500

出　　处：《中国抗生素杂志》2014年第3期207-209,233,共4页Chinese Journal of Antibiotics

基　　金：国家"重大新药创制"科技重大专项:中国药物技术创新及产业化战略联盟(项目编号:2010ZX09401-402)

摘　　要：目的从注射用盐酸头孢唑兰样品中分离制备头孢唑兰有关物质,并进行结构鉴定,为质量研究提供杂质对照品。方法采用制备色谱进行分离纯化,通过NMR、MS进行结构解析。结果制备分离得到3个化合物,分别为咪唑并[1,2-b]哒嗪、头孢唑兰的Δ3-异构体和去咪唑并哒嗪头孢唑兰。结论头孢唑兰的Δ3-异构体和去咪唑并哒嗪头孢唑兰为新化合物。Objective To provide reference impurities for drug quality study, the related substances in cefozopran hydrochloride for injection were isolated and identified. Methods Related substances were separated by preparative RP-HPLC; The structures of the related substances were elucidated based on the analysis of NMR and MS data. Results Three compounds were obtained and identified as imidazo[1,2-b]pyridazin, il3-isomer of cefozopran and des-imidazopyridazine-cefozopran, respectively. Conclusion △3-isomer of cefozopran and desimidazopyridazine-cefozopran are new compounds.

关 键 词：盐酸头孢唑兰 有关物质 分离纯化 头孢唑兰的△3-异构体 去咪唑并哒嗪头孢唑兰 

分 类 号：R978.1[医药卫生—药品]