HPLC-柱切换法归属青霉素钠有关物质中的聚合物分析___
Analysis of polymer impurities in related substances of benzylpenicillin sodium by HPLC-column-switching
分类号：
出版年·卷·期（页码）：2009,29 (10):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：在缺少杂质β-内酰胺抗生素聚合物对照品的条件下，定位青霉素钠在RP-HPLC系统中的聚合物色谱峰，进而实现β-内酰胺抗生素凝胶色谱系统(GFC)聚合物分析与RP-HPLC系统有关物质分析方法的统一。方法：采用6.0版欧洲药典青霉素钠的HPLC分析方法，利用各种专属性加速试验结合紫外特征吸收光谱及柱切换技术，在HPLC色谱图中定位各类青霉素杂质。结果：杂质p可以作为表征青霉素聚合物的指针性杂质，实现凝胶色谱系统和RP-HPLC的统一。结论：丰富了β-内酰胺抗生素聚合物分析方法，为实现对β-内酰胺抗生素聚合物杂质的有效控制提供了新思路。
-----英文摘要：---------------------------------------------------------------------------------------
Objective:To identify the polymer impurities in RP-HPLC chromatogram of benzylpenicillin sodium without any references,thus to realize the β-lactam antibiotics analysis unification between the polymer impurity(gel filtration chromatography,GFC) and the related substances(RP-HPLC).Methods:The 6.0 edition of European Pharmacopoeia HPLC method of benzylpenicillin sodium has been adopted.This issue also employs kinds of selectivity accelerated experiments,UV spectrum characteristics and the Dionex column-switching system to analyse the impurities in benzylpenicillin sodium RP-HPLC chromatogram.Results:GFC and RP-HPLC are well unified to find p as the index of the polymer impurity.Conclusion:The analysis of polymer impurities in β-lactam antibiotics become diverse.And it is helpful to realize more powerful control over polymer impurities in β-lactam antibiotics.
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