建立了高效液相色谱(HPLC)测定丙交酯纯度的方法.解决了分析过程中丙交酯水解不稳定的问题.在HPLC分析过程中,无水的有机流动相不能实现丙交酯与其它杂质的分离,有机溶剂和水的混合溶液作流动相能有效改善丙交酯与其它杂质的分离效果.通过对实验条件的摸索,并对丙交酯水解动力学进行研究,发现丙交酯在选定的色谱条件下,在流动相中的水解反应具有准一级反应动力学的特征,由此可对丙交酯进行定量分析.实验表明,相对标准偏差RSD＜1.0%,方法切实可行.
A new analytical method has been developed for determination of L-lactide purity by reverse phase HPLC (RP-HPLC). The unstable problem of the L-lactide hydrolysis was solved in the analytical process. L-lactide could not be separated from its impure mixture in anhydrous organic mobile phases, and the mobile phases of water and organic mixing solutions were used to realize the separation effectively. The L-lactide hydrolysis kinetics was proved as pseudo-first-order reaction in the mobile phase of the given RP-HPLC condition by the experiments, so that, the L-lactide purity could be quantitatively determined thereby. The feasibility of the method has been evaluated by using relative standard deviation(RSD). The results show RSD < 1.0%, which testifies that the method is feasible.
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