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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。
OBJECTIVE: To locate the polymer peaks of penicillin sodium in the RP-HPLC system in the absence of an impurity β-lactam antibiotic polymer reference standard, thereby enabling the analysis of the β-lactam antibiotic gel chromatography system (GFC) polymer Unification of methods of material analysis with RP-HPLC systems. METHODS: HPLC analysis of penicillin sodium version 6.0 European Pharmacopoeia was performed using various proprietary accelerated tests combined with UV-Vis absorption spectroscopy and column switching techniques to locate various penicillin impurities in the HPLC chromatogram. Results: The impurity p can be used as a pointer impurity for the characterization of penicillin polymers, achieving the unification of gel chromatography system and RP-HPLC. CONCLUSION: This method enriches the methods of β-lactam antibiotic polymer analysis and provides a new idea for the effective control of β-lactam antibiotic polymer impurities.