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目的建立注射用头孢地嗪钠聚合物凝胶色谱分析方法。方法 Sephadex G-10色谱柱,流动相A为0.02 mol·L~(-1)磷酸盐缓冲液(pH 7.0),流动相B为超纯水,流速1.0 mL·min~(-1),检测波长为254 nm。结果在10～30 g·L~(-1)范围内,样品浓度与聚合物峰面积线性良好,r=0.999 1。头孢地嗪钠对照品在0.05～0.15 g·L~(-1)范围内具有良好线性,r=0.999 8。结论本方法简便、准确、重现性好,适用于注射用头孢地嗪钠聚合物的定量检测。
Objective To establish a gel chromatography method for cefodizime sodium injection for injection. Methods The mobile phase A was 0.02 mol·L -1 phosphate buffer (pH 7.0) and the mobile phase B was ultrapure water at a flow rate of 1.0 mL · min -1 on a Sephadex G-10 column. The wavelength is 254 nm. Results In the range of 10 ~ 30 g · L ~ (-1), the linearity of the sample was linear with the polymer peak area, r = 0.999 1. Cefodizime sodium reference substance in the range of 0.05 ~ 0.15 g · L ~ (-1) has a good linearity, r = 0.999 8. Conclusion The method is simple, accurate and reproducible. It is suitable for the quantitative determination of Cefodizime sodium polymer for injection.