高效体积排阻色谱与多角激光光散射仪联机测定低分子肝素分子量及分子量分布

Determination of Molecular Weight and Molecular Weight Distribution of Low Molecular Weight Heparin by High Performance Size Exclusion Chromatograghy with Multiangle Laser Light Scatter

目的测定低分子肝素的分子量及其分布。方法高效体积排阻色谱,以0.2mol·L-1硫酸钠水溶液(pH5.0)为流动相,TSK-GELG2000SWxl凝胶色谱柱,示差折光检测器与多角激光光散射仪联用。结果获得了供试品的分子量与分子量分布,并与《欧洲药典》中规定的高效体积排阻色谱法的测定结果比较,结果一致。结论本法不需要分子量对照品,可以直接测定低分子肝素分子量及其分布,快速简便,结果该确。

OBJECTIVE To determine the molecular weight and molecular weight distribution of low molecular weight heparin（LMWH）. METHODS A high performance size exclusion chromatograghy（HPSEC） in conjunction with refractive index detector and mutiangle laser light scatter（MALLS）, was performed on a TSK-GEL G2000SWx1 column, using 0.2 mol·L^-1（pH 5.0） sodium sulfate as mobile phase. RESULTS The molecular weight and molecular weight distribution obtained by HPSEC/MALLS were complied with HPSEC of European Pharmacopoeia. CONCLUSION HPSEC/MALLS can directly determine the absolute weight and the distribution of LMWH without molecular calibrants, and the method is fast, simple and accurate.