阴离子交换色谱法用于肝磷脂钠的纯度评价

Impurity Evaluation of Heparin Sodium by Anion Exchange Chromatography

介绍了一种用于对肝磷脂中过硫酸化软骨素硫酸盐(OSCS)分离和定量的高效液相色谱(HPLC)方法。该方法使用阴离子交换色谱实现了肝磷脂和OSCS的完全分离,并用紫外吸收法对肝磷脂和OSCS进行了定量。实验结果表明,该方法不但具有重现性好和分析速度快(10min)的优点,而且可以在OSCS浓度低于总浓度1%时也能够对其进行有效检测。这种HPLC方法突破了毛细管电泳分析肝磷脂方法固有的局限性。

This article describes a simple and easy HPLC method to separate and quantify oversulfated chondroitin sulfate （OSCS） in the presence of heparin. The method uses anion exchange chromatography to achieve complete resolution between heparin and OSCS, and UV absorption to quantify the concentrations of heparin and OSCS. The results demonstrate that the method not only generates reproducible, fast separations （10 min）, but also detects OSCS at a concentration of less than 1% of overall content. The HPLC method addresses the limitations inherent with the capillary electrophoresis method for heparin analysis.