凝胶色谱法测定注射用头孢地嗪钠聚合物

Determination of polymers in cefodizime sodium for injection by gel chromatography

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。

AIM To establish a gel chromatography method for the determination of the polymers in cefodizime sodium for injection.METHODS The column was Sephadex G-10,the mobile phase A was 0.02 mol·L^（-1） phosphate buffer solution（pH 7.0）,and the mobile phase B was ultrapure water.The flow rate was 1.0 mL·min^（-1）,and the detection wavelength was 254 nm.RESULTS The calibration curve of the polymers in cefodizime sodium was linear in the concentration range of 10 - 30 g·L^（-1）（r = 0.999 1） and the calibration curve of contrast sample was linear in the concentration range of 0.05 - 0.15 g·L^（-1）（r = 0.999 8）.CONCLUSION This method is simple,accurate,reproducible and applicable for the determination of the polymers in cefodizime sodium.