Research on quality control of Picrorhiza scrophulariiflora total glycosides capsules based on multi-wavelength-UPLC fingerprint and multi-component content determination
Research on quality control of Picrorhiza scrophulariiflora total glycosides capsules based on multi-wavelength-UPLC fingerprint and multi-component content determination
丁丽 1蔡楠 2宋兆辉 3何毅4
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作者信息
1. 天津中医药大学,天津 301617
2. 天士力医药集团股份有限公司研究院现代中药开发中心,天津 300410
3. 现代中药创制全国重点实验室,天津 300410
4. 天津市组分中药重点实验室,天津 300410
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摘要
目的 建立多波长-超高效液相色谱(UPLC)测定胡黄连总苷胶囊指纹图谱及多成分的含量测定方法.方法 采用ACQUITY UPLC BEH C8色谱柱(2.1 mm × 100 mm,1.7 µm),流动相为0.1％甲酸-乙腈梯度洗脱,检测波长为 0～6 min 260 nm、6～10 min 300 nm、10～22 min 270 nm,流速为 0.35 ml/min,柱温 30℃.结果 在建立的指纹图谱中共标定了 16个共有峰,并用对照品指认11个共有峰,指纹图谱相似度均≥ 0.99;测定其中5个成分(草夹竹桃苷、香草酸、胡黄连苷Ⅰ、胡黄连苷Ⅱ、胡黄连苷Ⅳ)的含量测定结果在范围内呈线性相关;平均加样回收率97.60％～103.90％,RSD为1.79％～2.14％;精密度、重复性、稳定性实验RSD均≤1.45％.结论 该方法重复性好、准确度高,可用于胡黄连总苷胶囊的质量控制研究.
Abstract
Objective To establish a multi-wavelength ultra-high performance liquid chromatography(UPLC)method for the determination of the fingerprint and the content of multi-components of Picrorhiza scrophulariiflora total glycosides capsules.Methods ACQUITY UPLC BEH C8 column(2.1 mm × 100 mm,1.7 μ m)was used,and the mobile phase was 0.1％formic acid-acetonitrile gradient elution.The detection wavelength was 0-6 min 260 nm,6-10 min 300 nm,and 10-22 min 270 nm,the flow rate was 0.35 ml/min,and the column temperature was 30 ℃.Results 16 common peaks were identified in the established fingerprint,and 11 common peaks were identified by reference substance,and the similarity of fingerprint were all≥0.99.The content of 5 components(oleander glycoside,vanillic acid,picroside Ⅰ,picroside Ⅱ,picroside Ⅳ)was determined linearly within the range.The average sample addition recovery rate was 97.60％-103.90％,and RSD was 1.79％-2.14％.The RSD of precision,repeatability and stability tests were all ≤ 1.45％.Conclusion The method is reproducible and accurate,and can be used for the quality control research of Picrorhiza scrophulariiflora total glycosides capsules.
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