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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

于明艳 李玉杰 凌霄

药学研究2017,Vol.36Issue(3):145-148,152,5.
药学研究2017,Vol.36Issue(3):145-148,152,5.DOI:10.13506/j.cnki.jpr.2017.03.006

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

于明艳 1李玉杰 1凌霄1

作者信息

  • 1. 山东省食品药品检验研究院,山东 济南 250101
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摘要

Abstract

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 2000SWXL column(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.

关键词

高分子聚合物/高分辨质谱/安全监测

Key words

Polymer/HRMS/Safety monitoring

分类

医药卫生

引用本文复制引用

于明艳,李玉杰,凌霄..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[J].药学研究,2017,36(3):145-148,152,5.

基金项目

山东省自然基金培养基金(No.ZR2015PH030) (No.ZR2015PH030)

药学研究

2095-5375

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