摘要
目的:建立硫酸软骨素注射液小分子杂质测定方法。方法:采用凝胶色谱与示差检测器考察硫酸软骨素注射液的小分子杂质含量,同时串连二极管阵列检测器以考察其各组分的纯度和组成。结果:硫酸软骨素注射液样品中小分子杂质得到有效分离,其Mw为2521,Mn为1763,DAD检测证实它们紫外光谱与硫酸软骨素近似。结论:本方法可作为硫酸软骨素注射液小分子杂质的检测方法。
Objective： To develop a determination methods of small molecular weight impurity in Chondroitin Sulfate injection. Methods： The small molecular impurities contents in the Chondroitin Sulfate injection were determined by gel permeation chromatography and Refractive Index Detector（RI）, at the same time the purity of each component by diodearray detector（DAD） in series were tested. Results： The small molecular weight impurity was effectively isolated, Mw is 2521 and Mn is 1763, whose Ultraviolet spectroscopy is similar to that of Chondroitin Sulfate that is proved by the DAD determination method. Conclusion： The method can be used to determine the small molecular weight impurity in the Chondroitin Sulfate injection.
出处
《河南大学学报（医学版）》
CAS
2006年第3期27-28,共2页
Journal of Henan University:Medical Science
关键词
硫酸软骨素注射液
小分子杂质
凝胶色谱
Chondroitin sulfate injection
Small molecular weight impurity
Gel permeation chromatography
