柱前衍生化高效液相色谱法测定前列地尔脂质体的包封率

Entrapment efficiency determination of Alprostadil Liposome by precolumn derivatization-HPLC

目的:建立测定前列地尔的分析方法并测定前列地尔脂质体的包封率方法:色谱柱:Hypersil-C_(18)柱,(250 mm×4.6mm,5μm);流动相:磷酸二氢钾溶液(0.02 mol·L^(-1)):乙腈=50:50;流速:1.0 mL·min^(-1);柱温:室温;检测波长:278 nm;进样量:20μL。采用 KOH 衍生化法测定前列地尔脂质体的包封率结果:在此液相条件下,衍生物得到很好的分离,平均回收率为99.1%,RSD 为0.8%(n=5),线性范围0.5～5.0μg·mL^(-1),最低检测限达0.1μg·mL^(-1),样品的包封率为88.0%～90.5%。结论:柱前衍生化高效液相色谱法适用于测定前列地尔脂质体包封率,具有方便、快捷、灵敏度高等优点。

Objective：To establish the method for determination of entrapment efficiency of alprostadil liposomel Method： Using acetonitrile KH2 PO4 solution （0.02 mol · L ^- 1 ） = 50：50 as mobile phase, the separation was performed on a Hypersil -C18 column（250 mm ×4. 6 mm,5 μm）at a flow rate of 1.0 mL · min^-1 ,the detection wavelength was 278 nm and the column temperature was room temperature, and the loading volume was 20 μL. Entrapment efficiency of liposomal alprostadil was detected by precolumn derivatization of KOH Results：At this condition, the drug derivatization was separated well. The average recovery of the chromatography method was 99. 1% and RSD was 0. 8% （n =5）. The calibration curve was linear in the range of 0. 5 - 5.0 μg · mL^-1 and the lowest limited concentration was nearly 0. 1 μg · mL^-1. The entrapment efficiency of the sample was 88.0% - 90. 5%. Conclusion ：The precolumn derivatization- HPLC technique could be used to determine entrapment efficiency of alprostadil liposomel. It is convenient, straight and has a good sensitization.