注射用美洛西林钠高分子杂质的研究

Study on the High Molecular Impurity for the Injection of Mezlocillin Sodium

关键词:  美洛西林  TSK  G-10  高分子聚合物  高分子杂质

Key words:  mezlocillin  TSK  G-10  high molecular polymer  high molecular impurity

摘要:

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pH 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。

Abstract:

OBJECTIVE To set up a method for the assay of high molecular impurities in Mezlocillin Sodium for injection by TSK gel, and to disguss the internal relationships of the results with those of related compounds and polymers. METHODS The analysis was carried on a TSKgel G2000SWxl column with a mobile phase of 0.005 mol·L^-1 phosphate buffer with the pH value of 7.0. The detection wavelength was 210 nm. 204 batches of samples were determined, correlative analysis was performed to the results. RESULTS The established method could determine the high molecular impurities in Mezlocillin Sodium for injection. The correlative analysis showed that the determined impurities include the polymers and the known impurities whose molecular were higher than Mezlocillin. CONCLUSION For the polymer analysis of β-lactams, TSK gel method can not replace Sephadex G-10 method. Further studies were required to identity peaks of known high molecular impurities and those of polymers during the analysis.