注射用盐酸头孢甲肟的杂质谱研究  

Impurity Profile Study of Cefmenoxime Hydrochloride for Injection

作　　者：夏佳 陈红娟[2] 席时东 XIA Jia;CHEN Hongjuan;XI Shidong(Ningbo Institute for Drug Control,Ningbo 315048,China;Nanjing University State Key Laboratory of Pharmaceutical Biotechnology,Nanjing 210046,China)

机构地区：[1]宁波市药品检验所,浙江宁波315048 [2]南京大学医药生物技术国家重点实验室,南京210046

出　　处：《中国现代应用药学》2023年第5期654-663,共10页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 建立UHPLC-TOF-MS法对注射用盐酸头孢甲肟的杂质结构进行研究。方法 采用UHPLC-TOF-MS联用,Waters UPLC HSS T3色谱柱(2.1 mm×100 mm,1.8μm),流动相A为0.1%甲酸,流动相B为乙腈,梯度洗脱,柱温40℃,流速为0.3 mL·min^(–1)。结果 注射用盐酸头孢甲肟中检出15个有关物质,并对各杂质的结构进行了推测。结论 本实验建立的UHPLC-TOF-MS方法可用于注射用盐酸头孢甲肟的杂质谱研究。OBJECTIVE To establish an UHPLC-TOF-MS method for the research of the impurity profile of cefmenoxime hydrochloride for injection. METHODS UHPLC-TOF-MS was used with Waters UPLC HSS T3 column(2.1 mm×100 mm,1.8 μm). The mobile phase consisted of 0.1% formic acid(A) and acetonitrile(B) with gradient program. The column temperature was 40 ℃. The flow rate was 0.3 mL·min^(–1). RESULTS There were 15 related substances detected in the sample, all of which were identified. CONCLUSION The UHPLC-TOF-MS method can be used for the related substances study of cefmenoxime hydrochloride for injection.

关 键 词：注射用盐酸头孢甲肟 有关物质 杂质谱 飞行时间质谱 

分 类 号：R917.101[医药卫生—药物分析学]