葡聚糖凝胶色谱法测定头孢替坦二钠中聚合物含量的方法研究

Study on Polymer of Cefotetan Disodium by Gel Chromatography

目的建立葡聚糖凝胶色谱法测定头孢替坦二钠中聚合物的方法。方法使用不锈钢凝胶色谱柱,安装于普通的带有紫外检测器的高效液相色谱仪上直接进行测定。结果蓝色葡聚糖2000的理论板数、头孢替坦的线性关系、头孢替坦聚合物的线性关系、重复性均达到定量测定的要求。结论用葡聚糖凝胶色谱法测定头孢替坦二钠中聚合物的含量操作方便、结果准确。

To set up a sephadex column chromatography method for the determination of polymer impurity in cefotetan disodium. Methotis Directly determine the polymer impurity with a normal liquid chromatography which is equipped a steel column with the glucosan gel as stational phase. Results The theoretical plate of blue glucosan 2000, the linear relation of cefotetan and that of cefotetan polymer, and its repeatability could all met the requirements. Conclusion This method for the determination of polymer impurity in cefotetan disodium is easy to carry out and the test result is accurate.