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-中国药房.PDF

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 ＊ 阚微娜 ，滕艳坤，杨宏伟（辽宁省食品药品检验所，沈阳 110023） + 中图分类号 R927.2；R973.5 文献标志码 A 文章编号 1001-0408（2014）09-0843-03 DOI 10.6039/j.issn. 1001-0408.2014.09.26 摘 要 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0.2mol/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。 关键词 高效体积排阻色谱；示差折光检测器；多角激光光散射仪；右旋糖酐70；分子质量 Determination of Molecular Weight of Dextran 70Raw Material by High Performance Size Exclusion Chr- omatography with Differential Refraction Detector and Multi-angle Laser Light Scatter KAN Wei-na ，TENG Yan-kun ，YANG Hong-wei （Liaoning Institute for Food and Drug Control ，Shenyang 110023，China ） ABSTRACT OBJECTIVE ：To establish the method for the determination of molecular weight of dextran 70raw 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 0.2mol/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. KEYWORDS High performance s