高效液相色谱法测定苯妥英钠脂质体包封率

Determination of the entrapment efficiency of phenytoin-sodium liposome by high performance liquicl chromatography

【目的】建立高效液相色谱法测定苯妥英钠脂质体包封率。【方法】采用反向高效液相色谱法,色谱柱为SHIM-PACKVP-ODS C18柱（150 mm×4.6 mm,5μm）;流动相为甲醇-水-磷酸（80：20：0.4）;流速：1 ml/min;检测波长：240 nm;柱温30℃。【结果】苯妥英钠浓度在2.5～80μg/ml之间线性良好,方法回收率为101.14%~106.98%,日间和日内精密度均小于5%（n=5）,测定的苯妥英钠脂质体的包封率为25.46±0.27%（n=3）。【结论】建立的测定方法灵敏、准确、重现性好。

[Objective] To establish a HPLC method for determination of the entrapment efficiency of phenytoin-sodium liposome. [Methods]The RP-HPLC method was used with a SHIM-PACK VP-ODS C18 （150 mm × 4.6 mm, 5 um）column. The mobile phase consisted of methanol-water-phosphoric acid （80：20：0.4）.The flow rate was 1 ml/min, the detection wavelength was set at 240 nm.The column temperature was at 30 ℃. [Results] The linear range of phenytoin-sodium was from 2.5 ug/ml to 80 ug/ml. The average recovery was 101.14%-106.98%.The intra-day precision and inter-day precision were less than 5%.The mean encapsulation efficiency of PHT-Na liposomes was 25.46 ± 0.27% （n = 3）. [ Conclusion ]The method was found to be sensitive, accurate and reproducible.