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目的:建立体积排阻色谱-质谱联用方法分离检测头孢曲松钠中聚合物的方法。方法:采用Zenix SEC-150色谱柱(7.8 mm×300 mm,3μm),流动相为5 mmol/L乙酸铵溶液,流速为0.5 ml/min,检测波长为254 nm,ESI电离源。结果:聚合物与主药分离度达到2.82,分析周期耗时20 min以内。头孢曲松钠聚合物包括7-ACA二聚物、7-ACA三聚物、脱乙酰基头孢噻肟内酯二聚物、7-ACT二聚物和7-ACT三聚物。结论:本方法为β-内酰胺类抗生素中聚合物的分离、分析及产品质量提高提供了依据。
OBJECTIVE: To establish a method for the determination of polymers in ceftriaxone sodium by size-exclusion chromatography-mass spectrometry. Methods: A Zenix SEC-150 column (7.8 mm × 300 mm, 3 μm) was used. The mobile phase consisted of 5 mmol / L ammonium acetate solution and the flow rate was 0.5 ml / min. The detection wavelength was 254 nm. Results: The resolution of the polymer and the main drug reached 2.82, and the analysis cycle took less than 20 minutes. Ceftriaxone sodium polymers include 7-ACA dimer, 7-ACA trimer, deacetyl cefotaxime lactone dimer, 7-ACT dimer and 7-ACT trimer. Conclusion: This method provides a basis for the separation, analysis and product quality improvement of β-lactam antibiotics.