高效分子排阻色谱法测定头孢拉定胶囊中的聚合物

Determination of the Polymer in Cefradine Capsule by High Performance Size Exclusion Chromatography

目的建立高效分子排阻色谱法测定头孢拉定胶囊中聚合物的方法。方法用TSKG2000SW色谱柱(7.8mm×300mm),紫外254nm检测,以头孢拉定对照品外标法计算聚合物含量,并与《中国药典》2005年版头孢拉定原料药中聚合物测定方法进行比较。结果本方法测定头孢拉定胶囊中聚合物的平均含量为1.0%,显著高于《中国药典》2005年版方法测定结果。结论高效分子排阻色谱法测定灵敏度高,准确性好,分析速度快,可有效控制头孢拉定胶囊中聚合物的含量。

Objective To establish a high performance size exclusion chromatography method to determine the polymer in cefradine capsule.Methods The high performance size exclusion chromatography system consisted of TSK G2000SW chromatographic column,ultraviolet 254 nm detection wavelength and 0.01 mol/L phosphate buffer solution（pH 7.0） as the mobile phase.Results The content of the polymer in cefradine capsule averaged 1.0%,significantly higher than the result by method specified in CHP2005.Conclusion The high performance size exclusion chromatography method is sensitive,accurat and fast.It can be used to control the polymer concent of cefradine capsule.