HPLC法测定5-氟尿嘧啶纳米粒的药物包封率

目的：制备5-氟尿嘧啶（5-FU）纳米粒，并采用高效液相色谱法测定纳米粒中5-FU的包封率。方法：采用凝胶柱过滤分离5-FU纳米粒中的游离药物，以HPLC为分析方法对纳米粒包封率进行测定。色谱条件：采用Agilent C₁₈柱（250 mm×4.6 mm，5 μm），以甲醇-水（10：90）为流动相，流速1.0 mL·min^-1，检测波长266 nm，柱温30 ℃，进样量为20 μL。结果：5-FU峰与溶剂峰分离良好，5-FU浓度在2~14 μg·mL^-1范围内线性关系良好（r=0.9998）；平均回收率在96.5%~97.8%之间。结论：该方法经方法学验证，可适用于5-FU纳米粒中药物包封率的测定。

Objective: To prepare 5-fluorouracil(5-FU) nanoparticles and establish an HPLC method for the determination of 5-FU. Methods: Free 5-FU(non-associated to the nanostructures)was separated from the nanoparticles by Sephadex gel,with HPLC on analysis for determination of entrapment efficiency of 5-FU nanoparticles.An Agilent C₁₈ column(250 mm×4.6 mm,5 μm)was used,and methanol-water(10:90)was used as the mobile phase.The flow rate was 1.0 mL·min^-1;the detection wavelength was 266 nm;the sample volume was 20 μL and the column temperature was 30 ℃. Results: the peak of 5-FU and solvent could be separated well.The linear range of 5-FU was 2-14 μg·mL^-1(r=0.9998).The average recovery was 96.5%-97.8%. Conclusion: This method is suitable for the assay of entrapment efficiency of 5-FU nanoparticles.

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