高效体积排阻色谱-示差折光检测器-多角激光光散射仪联用测定右旋糖酐70原料药的分子质量

Determination of Molecular Weight of Dextran 70 Raw Material by High Performance Size Exclusion Chromatography with Differential Refraction Detector and Multi-angle Laser Light Scatter

目的:建立测定右旋糖酐70原料药的分子质量的方法。方法:采用不需要对照品的高效体积排阻色谱-示差折光检测器-多角激光光散射仪(HPSEC-RID-MALLS)联用法,另与《中国药典》方法即HPSEC-RID法(采用3种来源对照品)测定3批样品重均分子质量(Mw)的结果进行比较。两种方法色谱柱均为TSK-GEL G4000SWXL凝胶色谱柱,流动相分别为0.2 mol/L氯化钠水溶液和0.71%硫酸钠水溶液(均含0.02%叠氮化钠)。结果:采用HPSEC-RID-MALLS法与采用其中2种来源对照品的HPSEC-RID方法测得的样品Mw结果相近。结论:HPSEC-RID-MALLS法不需要对照品,可直接测定样品的分子质量,方法更简便、快速,且结果准确。

OBJECTIVE： To establish the method for the determination of molecular weight of dextran 70 raw material. METH- ODS： High-performance size exclusion chromatography-differential refraction detector-multi-angle laser light scatter （HP- SEC-RID-MALLS） were applied together. Molecular weight （Mw） of 3 batches of samples were determined by HPSEC-RID with substance control from 3 sources stated in Chinese Pharmacopoeia. The determination of 2 methods were performed on TSK-GEL G4000SWXL gel column with 0.2 mol/L sodium chloride solution and 0.71% sodium sulfate solution （all containing 0.02 % sodium azide） as mobile phase, respectively. RESULTS： Mw of HPSEC-RID-MALLS was similar to that of HPSEC-RID with substance control from 2 sources. CONCLUSIONS： HPSEC-RID-MALLS method can be used to detect absolute molecular weight of sample directly without substance control, and it is simpler, rapider and more accurate.