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目的建立TSK凝胶测定注射用美洛西林钠高分子杂质的方法,探讨高分子杂质与有关物质及聚合物的关系。方法选用TSKgel G2000SWxl色谱柱,流动相为p H 7.0的0.005 mol·L?1磷酸盐缓冲液,检测波长为210 nm。对204批次样品进行检测,检测结果与Sephadex G-10、有关物质结果进行相关性分析。结果所建立的方法能有效检出注射用美洛西林钠中的高分子杂质。相关性分析表明,TSK系统检出的杂质包括聚合物以及分子量高于美洛西林的已知杂质。结论 TSK方法不能取代G-10方法,采用TSK色谱系统测定β-内酰胺类抗菌药物聚合物时,需进行充分的研究,以排除高分子杂质(非聚合物)对于聚合物测定的影响。
Objective To establish a method for the determination of polymer impurity of mezlocillin sodium for injection by TSK gel and to explore the relationship between polymer impurities and related substances and polymers. Methods TSKgel G2000SWxl column was used. The mobile phase was 0.005 mol·L -1 phosphate buffer of p H 7.0. The detection wavelength was 210 nm. 204 batches of samples were tested, the test results and Sephadex G-10, the relevant material results were analyzed. Results The established method can effectively detect macromolecular impurities in mezlocillin sodium for injection. Correlation analysis showed that impurities detected by the TSK system include polymers and known impurities with a higher molecular weight than mezlocillin. Conclusion The TSK method can not replace the G-10 method. When the TSK chromatographic system is used for the determination of β-lactam antibiotic polymers, sufficient studies must be conducted to exclude the influence of polymer impurities (non-polymers) on the polymer determination.