RP-HPLC法测定紫杉醇脂质体的药物包封率

目的：建立紫杉醇脂质体药物包封率的测定方法。方法：采用葡聚糖凝胶G-50 柱色谱法分离紫杉醇脂质体和游离药物，用RP-HPLC 法检测紫杉醇的量，计算脂质体中紫杉醇的包封率；色谱条件：采用Platisil-ODS（250 mm×4.6 mm，5 μm）色谱柱，以甲醇-水（含0.1% 三乙胺和0.67% 冰乙酸）（80：20）为流动相，流速1.0 mL·min^-1，检测波长227 nm，柱温为室温。结果：紫杉醇与辅料及溶剂的色谱峰分离良好，峰形很好；紫杉醇线性范围0.5~50 μg·mL^-1（r=0.999 3），加样回收率范围为99.66%~100.8%，包封率范围为90.29%~91.65%。结论：本方法能快速检测紫杉醇脂质体中紫杉醇含量及包封率。

Objective: This study establishes the determination method of entrapment efficiency of paclitaxel liposome. Methods: The liposomal paclitaxel were separated well from free paclitaxel by the Sephadex G-50 chromatography and was detected with RP-HPLC method. A Platisil-ODS(250 mm×4.6 mm,5 μm)analytical column was used at room temperature,and the mobile phase was composed of methanol-water(containing 0.1% triethylamine and 0. 67% glacial acetic acid)(80:20)at a flow rate of 1.0 mL·min^-1,and the detection wavelength was 227 nm. Results: Paclitaxel peak was well separated with liposome excipients peak and solvent peak with a good peak shape. The linear range of paclitaxel was 0. 5-50 μg·mL^-1(r=0.999 3),the average recovery was 99.66%-100.84% and the entrapment efficiency of the liposomal paclitaxel was 90.29%-91.65%. Conclusion: The method can quickly detect the encapsulation efficiency of liposomal paclitaxel．

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