HPLC和MS法研究头孢噻吩钠有关物质的种类与含量

Study on Varieties and Contents of Related Substances in Cefonicid Sodium by HPLC and MS

目的:采用高效液相色谱法和质谱法研究头孢噻吩钠有关物质的种类和含量。方法:采用自身对照法对杂质谱进行定量测定,并采用UPLC-MS初步鉴定杂质种类。结果:通过对有关物质的归属和含量的分析研究,确定了可能存在6种物质,根据结构推断6种物质可能有抗菌性和毒性。结论:该方法简便、稳定性和重复性好,可用于头孢噻吩钠有关物质和含量的检查。

Objective： To study the varieties and contents of related substances in cefalotin sodium by HPLC and MS. Methods： The quantitative determination of impurity spectra was carried out using self-contrast method, and UPLC-MS was used to preliminarily i- dentify the variety of impurities. Results： Through the study on the ascription and content of the related substances, there were 6 substances existing in cefalotin sodium, and through the structure analysis, the 6 substances showed antibiotic action and toxicity. Conclusion： The method is simple, stable and repeatable, which can be used for the determination of cefalothin sodium and related substances.