LC-MS／MS 法分析注射用头孢唑林钠中的有关物质

摘要

目的：建立对注射用头孢唑林钠中有关物质进行定性分析的 LC-MS/MS 法。方法采用 Phenome-nex ODS（250 mm×4．6 mm，5μm）为色谱柱；10 mmol 醋酸铵水溶液为流动相 A，乙腈为流动相 B 的挥发性流动相线性梯度洗脱。采集有关物质的 PDA 谱、质谱母离子及子离子谱，并进行结构解析，推测有关物质的结构。结果在所建立的条件下，注射用头孢唑林钠中有关物质分离良好，检出11个有关物质峰。结论本文建立的LC-MS/MS 法可有效地分离分析注射用头孢唑啉钠中的有关物质，并为其质量控制和工艺纯化提供技术参考。%Objective To establish the identification of the related substances in Cefazolin sodium for injec-tion by LC-MS/MS method.Methods High pressure/performance liquid chromatography (HPLC)sepa-ration was carried out on Phenomenex ODS (250×4.6 mm,5 μm)with a gradient mobile phase consisting of 10 mmol/L ammonium acetate and pure acetonitrile.The PDA,parent ions and the corresponding prod-uct ions spectra of all the related substance in Cefazolin sodium for injection were determined.Results Good resolution of Cefazolin sodium and their main related substances were achieved.Eleven related sub-stances in Cefazolin sodium for injection were detected by LC-MS/MS.Conclusion The established method is effective in the separation and identification of the related substances in Cefazolin sodium for in-jection and the results are useful for its quality control.