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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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HPLC方法同时测定清热利胆片中10个成分含量

Simultaneous determination of ten components in Qingre Lidan tablets by HPLC

作者(英文):
分类号:R917
出版年·卷·期(页码):2019,39 (4):644-651
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立同时测定清热利胆片中绿原酸、迷迭香酸、黄芩苷、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、和厚朴酚、厚朴酚10个指标成分含量的HPLC方法。方法:采用WondaSil C18色谱柱(4.6 mm×250 mm,5 μm),以0.3%磷酸水溶液(A)-甲醇(B)为流动相进行梯度洗脱,流速1 mL·min-1,柱温37℃,检测波长分别为327 nm(绿原酸、迷迭香酸)、280 nm(黄芩苷)、254 nm(芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚)和294 nm(和厚朴酚、厚朴酚)。结果:清热利胆片中10个指标成分可实现完全分离,在一定的浓度范围内线性关系良好。方法的精密度、稳定性、重复性符合《中华人民共和国药典》2015年版中药品质量标准分析方法验证指导原则(四部9101)的要求(RSD ≤ 2.0%);平均回收率(n=6)在94.8%~99.5%范围内,RSD在0.93%~2.1%范围内。3批清热利胆片中绿原酸、迷迭香酸、黄芩苷、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚、和厚朴酚、厚朴酚的含量范围分别为0.281~0.320、0.252~0.281、1.876~2.090、0.127~0.144、0.178~0.198、0.146~0.163、0.492~0.565、0.122~0.142、0.630~0.673、0.954~1.014 mg·片-1结论:该方法能够用于同时检测清热利胆片中10个化学成分。

-----英文摘要:---------------------------------------------------------------------------------------

Objective:To develop an HPLC method for the determination of chlorogenic acid, rosmarinic acid, baicalin, aloe-emodin, rhein, emodin, chrysophanol, physcion, honokiol and magnolol in Qingre Lidan tablets. Methods:The analysis was performed on a WondaSil C18 column (4.6 mm×250 mm, 5 μm) eluted with mobile phase of 0.3%phosphoric acid aqueous solution (A) and methanol (B) in a linear gradient mode. The flow rate was kept at 1 mL·min-1 and the column temperature was set at 37℃. The detector wavelengths were 327 nm (chlorogenic acid, rosmarinic acid), 280 nm (baicalin), 254 nm (aloe-emodin, rhein, emodin, chrysophanol, physcion) and 294 nm (honokiol, magnolol). Results:10 selected components in Qingre Lidan tablets were separated satisfactorily. All the components exhibited good linear correlation in the given concentration range (r=0.999 9-0.999 3). The precision, stability and repeatability were all fit to the requirement of the guiding principle about the methodology validation in Chinese Pharmacopoeia (Edition 2015) (RSD ≤ 2.0%). The average recoveries (n=6) of the 10 components were 94.8%-99.5%with the RSD of 0.93%-2.1%. Three batches of samples were tested and the contents of ten components were between 0.281-0.320, 0.252-0.281, 1.876-2.090, 0.127-0.144, 0.178-0.198, 0.146-0.163, 0.492-0.565, 0.122-0.142, 0.630-0.673 and 0.954-1.014 mg per tablet, respectively.Conclusion:This method is suitable for simultaneous determination of 10 contents in Qingre Lidan tablets.

-----参考文献:---------------------------------------------------------------------------------------

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