分子排阻色谱法测定头孢克肟聚合物

Determination of Polymers in Cefixime by Molecular-exclusion Chromatography Method

目的:建立用分子排阻色谱法分析头孢克肟高分子聚合物的方法。方法:采用SephadexG10色谱柱(300 mm×16mm,40～120μm),流动相A为0.1 mol·L^(-1)磷酸盐缓冲液(pH 7.0),流动相B为超纯水,流速1.5 ml·min^(-1),检测波长:254nm。结果:头孢克肟在5～80 mg·ml^(-1)范围内与头孢克肟高分子聚合物的峰面积呈良好的线形关系(r=0.999 3)。头孢克肟在5～400μg·ml^(-1)的范围内与头孢克肟缔合物的峰面积也呈良好的线性关系(r=0.999 7)。结论:该方法能较好地分离头孢克肟与其聚合物,且精密度、准确度均能满足质量控制的要求。

Objective： To establish a molecular-exclusion chromatography method for determination of polymers in eefixime. Method： The analytical column was Sephadex Gl0（300 mm × 16 mm,40-120 μm） with mobile phase A of 0. 1 mol·L^-1 phosphate buffer （ pH 7.0）, mobile phase B of pure water, the flow rate of 1.5 ml·min ^- l and the detection wavelength was 254 nm. Result： The calibration carve of the polymers was linear within cefixime concentration range of 5-80mg·ml ^-1 （r =0. 999 3 ） and another calibration curve was linear within eefixime concentration range of 5-400μg·ml^-1 （r =0. 999 7）. Conclusion： The method is promising for the separation of polymers, and the accuracy and precision are suitable for the drug quality contol.