注射用盐酸头孢甲肟的杂质谱研究

Impurity Profile Study of Cefmenoxime Hydrochloride for Injection

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，1.8 μm)，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。

Abstract: 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.