苯扎贝特纳米脂质载体的包封率测定

Determination of Entrapment Efficiency of Bezafibrate Nanostructured Lipid Carriers

关键词:  苯扎贝特  纳米脂质载体  包封率  葡聚糖凝胶柱层析法  高效液相色谱法

Key words:  bezafibrate  nanostructured lipid carriers  entrapment efficiency  Sephadex gel column chromatography  HPLC

摘要:

目的 建立苯扎贝特纳米脂质载体包封率的测定方法。方法 采用葡聚糖凝胶柱层析法分离苯扎贝特纳米脂质载体中的游离药物，高效液相色谱法测定其含量，计算包封率。色谱条件：采用Agilent ZORBAX SB-C₁₈柱(250 mm×4.6 mm，5 μm)，流动相为0.01 mol·L^-1磷酸盐缓冲液(pH 3.0)-甲醇(30∶70)，流速：1.0 mL·min^-1，检测波长：230 nm，进样量：20 μL。结果 苯扎贝特峰与杂质峰的分离度良好，苯扎贝特浓度在4.44~177.6 μg·mL^-1内与峰面积呈良好的线性关系(r=0.999 9)，平均回收率为99.23%(RSD=0.68%)。3批苯扎贝特纳米脂质载体的包封率均>75%。结论 本方法简便、准确，灵敏度高，可用于苯扎贝特纳米脂质载体的质量控制。

Abstract:

OBJECTIVE To establish a method for the determination of entrapment efficiency of bezafibrate nanostructured lipid carriers. METHODS Free bezafibrate was separated from the nanostructured lipid carriers by Sephadex gel, with HPLC on analysis for determination of entrapment efficiency of bezafibrate nanostructured lipid carriers. An Agilent ZORBAX SB-C₁₈ column(250 mm×4.6 mm, 5 μm) was used, and 0.01 mol·L^-1 phosphate buffer (pH 3.0)-methanol(30∶70) was used as the mobile phase. The flow rate was 1.0 mL·min^-1. The detection wavelength was 230 nm. The sample volume was 20 μL. RESULTS The peak of bezafibrate and impurity could be separated well. The linear range of bezafibrate was 4.44-177.6 μg·mL^-1(r=0.999 9). The recovery of bezafibrate was 99.23%(RSD=0.68%). The entrapment efficiency of 3 batches of bezafibrate nanostructured lipid carriers were all >75%. CONCLUSION The proposed method is simple, applicable and accurate for determination of entrapment efficiency of bezafibrate nanostructured lipid carriers.