HPLC法测定黄芩苷化学原料药中主成分的含量及有关物质

承德医学院学报 ›› 2019, Vol. 36 ›› Issue (3): 192-195.

HPLC法测定黄芩苷化学原料药中主成分的含量及有关物质

毕彤¹, 董海荣², 朱磊²

1.天津药物研究院药业有限责任公司,天津 300000;
2.颈复康药业集团有限公司

收稿日期:2019-01-10 出版日期:2019-06-10 发布日期:2021-11-18

CONTENT DETERMINATION OF PRINCIPAL COMPONENT AND RELATED SUBSTANCES IN BAICALIN CHEMICAL RAW MATERIAL BY HPLC

BI Tong, DONG Hai-rong, ZHU lei

TIPR Pharmaceutical Responsible Co.,Ltd., Tianjin 300000, China

Received:2019-01-10 Online:2019-06-10 Published:2021-11-18

摘要/Abstract

摘要： 目的:建立测定黄芩苷原料药中主成分含量和有关物质的方法。方法:采用高效液相色谱（HPLC）法,黄芩苷和有关物质的流动相分别采用甲醇-水-磷酸（47：53：0.2）、甲醇-水-磷酸（42：58：0.2）,检测波长均为280nm。结果:黄芩苷在10.6922µg/ml~106.922µg/ml范围内线性关系良好,平均回收率为99.7%（RSD=0.96%）,三批黄芩苷原料药中黄芩苷的含量分别为89.9%、91.2%和90.7%。专属性试验表明,有关物质测定系统的分离度、检测灵敏度均达到要求。结论:本研究建立的HPLC法测定黄芩苷原料药中主成分和有关物质含量的方法,快速、简便、专属性强,能有效控制黄芩苷原料药的质量。

关键词: 黄芩苷, 原料药, 有关物质, 含量测定, 高效液相色谱法（HPLC）

Abstract: Objective: To establish the method for content determination of baicalin and related substances in baicalin chemical raw material. Methods: High performance liquid chromatography (HPLC) was used in this study, the mobile phase of baicalin and related substances were respectively methanol-water-phosphoric acid (47:53:0.2) and methanol-water-phosphoric acid (42:58:0.2), the detection wavelength was all 280nm. Results: The linear range of baicalin was 10.6922µg/ml~106.922µg/ml, the average recovery rate was 99.7% (RSD=0.96%). The baicalin content in 3 batches baicalin chemical raw material were respectively 89.9%, 91.2% and 90.7%. Specific test showed that the resolution and detection sensitivity of measuring system for related substances all reach the testing requirement. Conclusions: The method for determination of principal component and related substances by HPLC in this study is rapid, simple and specific, and suitable for the quality control baicalin chemical raw material.

Key words: Baicalin, Raw material, Related substances, Content determination, High performance liquid chromatography (HPLC)

中图分类号:

R917

毕彤, 董海荣, 朱磊. HPLC法测定黄芩苷化学原料药中主成分的含量及有关物质[J]. 承德医学院学报, 2019, 36(3): 192-195.

BI Tong, DONG Hai-rong, ZHU lei. CONTENT DETERMINATION OF PRINCIPAL COMPONENT AND RELATED SUBSTANCES IN BAICALIN CHEMICAL RAW MATERIAL BY HPLC[J]. Journal of Chengde Medical University, 2019, 36(3): 192-195.

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