微柱离心高效液相色谱法测定盐酸阿霉素磁性热敏脂质体包封率

目的建立微柱离心高效液相色谱法测定盐酸阿霉素磁性热敏脂质体包封率。方法采用SephadexG-50分离脂质体和游离药物,采用高效液相色谱法测定过柱后游离药物含量和过柱前脂质体中药物含量,通过包封率计算公式得出盐酸阿霉素磁性热敏脂质包封率。结果在所选色谱条件下,脂质体其他组分不干扰样品的测定,盐酸阿霉素在5.0100.0μg/m l（r=0.9992,n=7）范围内线性关系良好。洗脱曲线研究结果表明微柱离心法能有效将盐酸阿霉素磁性热敏脂质体与游离药物分离,低、中、高3种浓度的微柱离心法平均加样回收率分别为（97.30±1.11）%、（95.97±1.26）%、（96.78±0.73）%,RSD分别为1.14%,1.32%,0.75%（n=3）。微柱离心高效液相色谱法测定3个不同批号盐酸阿霉素磁性热敏脂质体平均包封率分别为（82.77±0.88）%、（83.03±1.38）%、（80.68±0.42）%（n=3）,RSD分别为1.06%、1.65%、0.51%。结论该方法准确度高,重复性好并方便快捷,可用于盐酸阿霉素磁性热敏脂质体包封率的测定。

Determination of Entrapment Efficiency of Doxorubicin Magnetic Thermosensitive Liposomes by Mini-column Centrifugation-Reversed-phase High Performance Liquid Chromatography

Objective To establish a mini-column centrifugation-reversed-phase high performance liquid chromatography method to determine the entrapment efficiency of doxorubicin magnetic thermosensitive liposomes.Methods A mini-column centrifugation was employed to separate the free drug from liposomes.The entrapment efficiency of doxorubicin magnetic thermosensitive liposomes was measured in free drug and liposomse before separation by reversed-phase high performance liquid chromatography.Results Under the chromatogram condition,application of the supplementary has effect on determination.A calibrated linear curve of doxorubicn hydrochloride concentration showed a good linear relation within a range of 5.0-100.0 μg/ml（r=0.9992,n=7）.The elution curve suggested that the liposome and drug were well separated.The recovery and RSD at the low,middle and high concentrations were（97.30±1.11）% and 1.14%,（95.97±1.26）% and 1.32%,（96.78±0.73）% and 0.75%,respectively（n=3）.The average entrapment efficiency of three batches of doxorubicin magnetic thermosensitive liposomes was（82.77±0.88）%,（83.03±1.38）% and（80.68±0.42）%（n=3） and RSD was 1.06%,1.65% and 0.51% respectively.Conclusion The method is accurate,reproducible,simple and applicable for the determination of entrapment efficiency of doxorubicin magnetic thermosensitive liposomes.