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胡黄连苷-Ⅱ原料药特征图谱研究及有关物质测定 被引量:2

Studies on HPLC characterization chromatograms for determination of related substances in raw material drug of picroside-Ⅱ
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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.
出处 《药物分析杂志》 CAS CSCD 北大核心 2015年第8期1436-1440,共5页 Chinese Journal of Pharmaceutical Analysis
关键词 胡黄连苷-Ⅱ 特征图谱 有关物质 原料药 质量控制 picroside- Ⅱ characterization chromatograms related substances raw material drug, quality control
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