凝胶色谱法测定注射用美洛西林钠舒巴坦钠中聚合物

Determination of Polymers in Mezlocillin Sodium-sulbactam Sodium for Injection by Gel Chromatography

目的建立一种利用葡聚糖凝胶柱分离测定注射用美洛西林钠舒巴坦钠中美洛西林钠聚合物的方法。方法Sephadex G-10色谱柱,流动相A为0.05 mol·L-1磷酸盐缓冲液(pH 7.0),流动相B为超纯水,流速为1.0 ml·min-1,检测波长为254 nm,进样量200μl。结果美洛西林对照品在20.2l～60.6μg·ml-1范围内与其峰面积成良好线性关系,r=0.9992。结论本方法简便、准确、重复性好,适用于注射用美洛西林钠舒巴坦钠聚合物的定量检测。

Objective To establish a glucose gel column method for the determination of mezlocillin poly- mers in mezlocillin sodium-sulbactam sodium for injection. Methods The column was Sephadex G-10, mobile phase A was 0.05 mol .L-1 phosphate buffer solution （pH 7.0） and mobile phase B was super pure water. The flow rate was 1.0 ml .min- 1while the detection wavelength was 254 nm. The injected sample volume was 200 μl. Results the calibration curve of the contrast sample was linear within the concentration range of 20.21-60.6 μg ml-1 （ r = 0. 9992）. Conclusion This method is simple, accurate, reproducible and applicable to the determination of poly- mers in mezlocillin sodium-sulbactam sodium for injection.