高效液相色谱梯度洗脱法测定水飞蓟素自微乳化制剂中水飞蓟宾的含量  

Determination of Silibinin Concentration in Silymarin Self-Emulsifying Microemulsion by High Performance Liquid Chromatography

作　　者：夏志高[1] 彭晓青[1] 朱幸仪[1] 柳彩阳 

机构地区：[1]广东省广州市第一人民医院药剂科,广东广州510180 [2]广东省广州市第一人民医院肾内科,广东广州510180

出　　处：《今日药学》2015年第6期432-434,共3页Pharmacy Today

摘　　要：目的对高效液相色谱梯度洗脱法测定水飞蓟素自微乳化制剂中水飞蓟宾的含量进行研究。方法色谱柱运用Symmetry C18,大小为3.9 mm×150 mm,5μm;流动相：混合溶剂A与混合溶剂B;流速设置为0.8 m L/min;将检测波长设置为288nm;控制色谱柱温度为40℃。结果在0.293 8-0.881 2μg范围内,水飞蓟宾的线性关系较好,线性回归方程为Y=1.553×106X＋14 001,r=0.999 7;精密度试验结果显示：RSD为0.82%,表明在24 h内水飞蓟素自微乳供试品溶液具有较好的稳定性;加样回收率试验结果显示RSD为0.70%,回收率为99.88%。结论对水飞蓟素自微乳化制剂中的水飞蓟宾含量运用高效液相色谱梯度洗脱法进行测定,具有较高的准确度和重复性,且能够为制定水飞蓟素自微乳化制剂质量标准提供重要依据。OBJECTIVE To investigate the value of determination of silibinin concentration in silymarin self-emulsifying microemulsion by high performance liquid chromatography. METHODS Symmetry C18 column was used and the size of the column was3. 9 mm × 150 mm,5 μm. The mobile phase including mixed solvent A and mixed solvent B and the velocity of mobile phase was 0. 8m L / min. The detection wavelength was set to be 288 nm and the column temperature was 40 ℃. RESULTS The linear relationship of silibinin was good in the range of 0. 293 8- 0. 881 2 μg,and the linear regression equation was Y = 1. 553 × 106 X ＋ 14 001,r = 0. 9997. Results of precision test showed that the value of RSD was 0. 82%,which meant that the silymarin self-emulsifying microemulsion for test had good stability in 24 h. The value of RSD was 0. 70%,and the recovery rate was 99. 88%. CONCLUSION Determination of silibinin concentration in silymarin self-emulsifying microemulsion by high performance liquid chromatography had high accuracy and its repeatability is high,thus it can be for reference for quality standard of the formulation of silymarin self-emulsifying microemulsion.

关 键 词：高效液相色谱梯度洗脱法 水飞蓟素自微乳化制剂 水飞蓟宾 

分 类 号：R284[医药卫生—中药学]