HPLC测定水飞蓟宾缓释纳米球的体外释放度

Determination of In Vitro Release of Silybin Sustained-release Microspheres by HPLC

目的建立水飞蓟宾缓释纳米球体外释放度的测定方法。方法采用高效液相色谱(HPLC),选用C18色谱柱(依利特,250mm×4.6mm,5μm),甲醇-0.05mol/L磷酸盐缓冲液(pH3.0)(49:51)为流动相,流速1.0ml/min,检测波长288nm,柱温25℃。结果上述色谱条件下,释放度测定时,水飞蓟宾在0.5~20μg/ml浓度范围内,峰面积(A)与药物浓度(C)有良好的线性关系,回归方程为A=30618C-2085.8(r=0.9999),平均回收率为101.85%,RSD为1.53%。结论该方法稳定、可靠、重现性好,可用于水飞蓟宾缓释纳米球体外释放过程中的含量测定。

Objective To develop a method for determination of in vitro release of silybin sustained-release microspheres. Methods The determination was performed by HPLC on a C18 column (Elite, 250 mm×4.6 mm, 5 μm) with methanol-0.05 mol/L phosphate buffer solution (pH 3.0)(49:51) as the mobile phase. The flow rate was 1.0 ml/min, the detection wavelength was 288 nm, and the column temperature was kept at 25 ℃. Results There was a good linear relationship between peak area (A) and drug concentration (C) in the concentration range of 0.5-20 μg/ml. The regression equation was A=30 618C-2085.8 (r=0.9999), the average recovery was 101.85 % and the RSD was1.53 %. Conclusion The method is stable, reliable and reproducible and can be used in the determination of in vitro release of silybin sustained-release microspheres.