Q-Exactive高分辨质谱仪分析注射用头孢哌酮钠舒巴坦钠中的高分子聚合物

Application of Q-Exactive high resolution mass spectrometry to analysis of the Polymer in Cefoperazone Sodium and Sulbactam Sodium for Injection

目的采用Q-Exactive四极杆静电场轨道阱高分辨质谱仪分析注射用头孢哌酮钠舒巴坦钠中的高分子聚合物及相关杂质。方法色谱柱为TSK GEL 2000SW_(XL)凝胶色谱柱(7.8 mm×30 cm,5μm),流动相为0.1%甲酸-乙腈(97∶3);离子源:ESI离子源;扫描模式:正/负离子扫描。结果本方法通过Q-Exactive四极杆静电场轨道阱一级质谱图分析注射用头孢哌酮钠舒巴坦钠中的高分子聚合物及相关杂质。结论本方法为分析注射用头孢哌酮钠舒巴坦钠中的高分子聚合物及相关杂质提供了一种新方法,进而可以对药品杂质控制和工艺优化提供参考结论。

Objective To establish a Q-Exactive high resolution mass spectrometry（ HRMS） method for the analysis of the polymer and impurities in Cefoperazone Sodium and Sulbactam Sodium for Injection.Methods The HPLC was performed on a TSK GEL 2000SWXLcolumn（ 7.8 mm × 30 cm,5 μm） with 0.1% Formic acid-acetonitrile（ 97∶3） as mobile phase.Data was collected under positive/negative ion modes with ESI as ion resource. Results The method analyzed the polymer and impurities in Cefoperazone Sodium and Sulbactam Sodium for Injection based on analysis the feature fragmentation from Q-Exactive.Conclusion This paper established a new method for quality control of the polymer and impurities in Cefoperazone Sodium and Sulbactam Sodium for Injection,and thus provided reference to its quality control and process optimization.