Analysis Method of Organic Acids Content in Ginkgo Biloba Extract Based on the Analytical Quality by Design

LI Jin-hao; ZHOU Ya-qing; XIE Jia-le; WANG Yuan-yuan; GONG Xing-chu

doi:10.12452/j.fxcsxb.24032102

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Analysis Method of Organic Acids Content in Ginkgo Biloba Extract Based on the Analytical Quality by Design

Scientific Papers | 更新时间：2024-11-26

- Analysis Method of Organic Acids Content in Ginkgo Biloba Extract Based on the Analytical Quality by Design
- Journal of Instrumental Analysis Vol. 43, Issue 11, Pages: 1735-1744(2024)
- 作者机构：
  
  1.天津中医药大学中药制药工程学院，天津 300193
  2.浙江大学智能创新药物研究院，浙江杭州 310018
  3.浙江大学药学院，浙江杭州 310058
  4.现代中药创制全国重点实验室，浙江杭州 310058
- 作者简介：
- 基金信息：
- DOI：10.12452/j.fxcsxb.24032102
  CLC： O657.7;R282
- Published：15 November 2024，
  
  Received：21 March 2024，
  
  Revised：20 May 2024，
- 稿件说明：
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李今豪,周雅青,颉佳乐,王元远,龚行楚.基于分析质量源于设计的银杏叶提取液中有机酸含量分析方法[J].分析测试学报,2024,43(11):1735-1744.

LI Jin-hao,ZHOU Ya-qing,XIE Jia-le,WANG Yuan-yuan,GONG Xing-chu.Analysis Method of Organic Acids Content in Ginkgo Biloba Extract Based on the Analytical Quality by Design[J].Journal of Instrumental Analysis,2024,43(11):1735-1744.
李今豪,周雅青,颉佳乐,王元远,龚行楚.基于分析质量源于设计的银杏叶提取液中有机酸含量分析方法[J].分析测试学报,2024,43(11):1735-1744. DOI： 10.12452/j.fxcsxb.24032102.

LI Jin-hao,ZHOU Ya-qing,XIE Jia-le,WANG Yuan-yuan,GONG Xing-chu.Analysis Method of Organic Acids Content in Ginkgo Biloba Extract Based on the Analytical Quality by Design[J].Journal of Instrumental Analysis,2024,43(11):1735-1744. DOI： 10.12452/j.fxcsxb.24032102.

摘要

基于分析质量源于设计（AQbD）理念建立了银杏叶提取液中6种有机酸含量的高效液相色谱-二极管阵列检测器（HPLC-DAD）分析方法。首先，使用鱼骨图确定潜在的关键方法参数，然后通过确定性筛选设计辨识关键方法评价指标，再采用逐步回归法建立关键方法参数与关键方法评价指标之间的定量关系，采用达标概率法建立了方法的可操作设计区域并成功验证。用Plackett-Burman设计评价分析方法的耐用性。该方法通过方法学验证，可用于银杏叶提取液中有机酸含量的测定。

Abstract

In this work，a high performance liquid chromatography-diode array detector（HPLC-DAD） was used to establish a quantitative method for the determination of six organic acids in Ginkgo biloba extract based on analytical quality by design（AQbD） concept. Firstly，potential critical method parameters（CMPs） were identified by Ishikawa diagram. Then the critical method attributes（CMAs） were identified by definitive screening design. A stepwise regression method was used to build quantitative models between CMAs and CMPs. The method operable design region was established by a probability-based method and verified successfully. The analytical method robustness was tested using the Plackett-Burman design. The method was verified and can be used for the determination of organic acids in Ginkgo biloba extract.

关键词

银杏叶分析质量源于设计实验设计可操作设计区域有机酸高效液相色谱

Keywords

Ginkgo bilobaanalytical quality by designdesign of experimentmethod operable design regionorganic acidshigh performance liquid chromatography

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