胡黄连苷-Ⅱ原料药特征图谱研究及有关物质测定  

Studies on HPLC characterization chromatograms for determination of related substances in raw material drug of picroside-Ⅱ

作　　者：李鹏[1] 薛明[1] 汪斌[1] 陈炜伟[1] 郑璐[1] 姚仲青[1] 

机构地区：[1]扬子江药业集团有限公司中药研究院,泰州225321

出　　处：《药物分析杂志》2015年第8期1436-1440,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：摘要目的：采用高效液相色谱法建立胡黄连苷-Ⅱ原料药特征图谱并测定有关物质。方法：采用Kromasil100—5C18色谱柱（250mm×4．6mm，5μm），流动相为乙腈-0．2％乙酸溶液（15．5：84．5），流速1mL·min-1，检测波长264nm，柱温30℃，进样量10μL。结果：建立了胡黄连苷-Ⅱ原料药的特征图谱，样品特征图谱有5个特征峰，仅有3个有关物质的面积百分比在0．1％以上，主成分与有关物质分别在本文色谱条件下分离良好。胡黄连苷-Ⅱ的线性范围为117．92～1887μg．mL。（r=0．9999，n=5）；平均回收率（n=6）为98．58％。结论：本方法准确，重复性好，可作为胡黄连苷，Ⅱ原料药质量控制时测定有关物质的方法。Objective ： To develop an HPLC method for determination of the related substances in raw material drug of picroside-Ⅱ . Methods： The analysis was conducted by RP-HPLC using a Kromasil 100-5 C18 column （250 mm ×4.6 mm,5 p,m）. The mobile phase was acetonitrile-0.2% acetic acid（ 15.5： 84.5）with a flow rate of 1.0 mL . min - 1. The detection wavelength was 264 nm. The column temperature was 30 ℃, and the injection volume was 10 μL. Results： The charaeterization chromatograms of the Picroside-Ⅱ was established. Five common peaks were separated in the test sample. Only 3 of the related substances had the area normalization content over 0. 1%. The prominent peak and the neighboring subsidiary peak were completely separated by the method. The linear range of picroside- Ⅱ was 117.92-1 887 μg. mL-1（ r = 0. 999 9, n = 5 ）, with an average recovery of 98.58% （ n = 6）. Conclusion：The method is precise and reproducible, which is reliable for the analysis of related substances in raw material drug of picroside- Ⅱ.

关 键 词：胡黄连苷-Ⅱ 特征图谱 有关物质 原料药 质量控制 

分 类 号：R917[医药卫生—药物分析学]