头孢地嗪水溶液中降解杂质成分的检测及表征

Detection and characterization of degradation impurities in cefodizime solution

摘要:

应用超高效液相色谱-串联质谱法分析头孢地嗪水溶液降解杂质成分。头孢地嗪水溶液经加热、酸碱及氧化破坏后，采用UPLC-MSE方法检测标准品及降解水溶液中杂质。依据保留时间、一级质谱母离子峰、二级质谱特征碎片分析确定头孢地嗪水解产物为反式异构体、Δ3异构体或其它降解杂质，加热、酸碱和氧化均会使杂质含量增加。头孢地嗪对热、酸、碱及氧均不稳定， 样品应于暗晾干燥处密封保存，且注射溶液后配制应尽快使用。

Abstract:

A method is described for the identification of degradation impurities in Cefodizime solution by ultra performance liquid chromatography and tandem mass spectrometry(UPLC-MS). UPLC-MS method was used to determine the degradation impurities of cefodizime solution at high temperature, acid-base and oxidation conditions. The method identified impurities as anti-form, Δ3-cephem form and degradation impurity based on analysis retention-times, full scan MS and MS2 spectra among extracts , and their content could be increased by heat, acid-base and oxidation. Cefodizime is unstable when exposed to head, acid, alkali and oxygen. Thus, it should be stored in cold, dark and relative humidity below 60%. In addition, the solution should be freshly used.