HPLC法测定依折麦布辛伐他汀纳米粒中药物含量及包封率

建立了高效液相色谱法测定依折麦布辛伐他汀固体脂质纳米粒中药物含量及包封率。采用Agilent SB-C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-0.025 mol/mL磷酸二氢钠水溶液(pH4.50)梯度洗脱,流速1 mL/min,检测波长分时段设置为234 nm或238 nm,柱温35℃;进样量20μL;采用葡聚糖凝胶过滤法测定依折麦布辛伐他汀纳米粒包封率。结果表明,依折麦布在2.090~45.978μg/mL浓度范围内线性关系良好(r=0.9998),平均回收率为98.79%(RSD=1.11%);辛伐他汀在2.182~48.013μg/mL浓度范围内线性关系良好(r=0.999 8),平均回收率为99.56%(RSD=0.70%);纳米粒胶体溶液中依折麦布的包封率为87.4%,辛伐他汀的包封率为83.1%。本方法简便、高效、准确,可用于依折麦布辛伐他汀纳米粒药物含量及包封率的测定。

Determination of Drug Content and Entrapment Efficiency of Ezetimibe and Simvastation Nanoparticles by HPLC

The HPLC method was established to determine the drug content and encapsulation efficiency of ezetimibe and simvastation nanoparticles.Detection conditions were as follows:chromatographic column was Agilent SB-C18 (4.6 mm×250 mm,5 μm);mobile phase was acetonitrile and 0.025 mol/mL sodium dihydrogen phosphate solution (pH4.50) for gradient elution with the flow rate lmL/min;the detection wavelength was 234 nm or 238 nm;the temperature of column was 35 ℃;the sample volume was 20 μL.The dextran gel filtration method was employed to isolate the nanoparticles for determination the encapsulation efficiency.The results showed that:the linear correlation was good (r=0.999 8) in the range of ezetimibe concentration 2.090～45.978 μg/ml,and the average recovery was 98.79％ with RSD 1.11％;the linear correlation was good (r=0.999 8) in the range of simvastation concentration 2.182～48.013 μg/ml,and the average recovery was 99.56％ with RSD 0.70％;and the encapsulation rates were 87.4％ for ezetimibe,83.1％ for sivastation.The detection method is simple,efficient,accurate for determining drug content and encapsulation efficiency of ezetimibe and simvastation nanoparticles.