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  

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

作　　者：李今豪 周雅青 颉佳乐 王元远 龚行楚 LI Jin-hao;ZHOU Ya-qing;XIE Jia-le;WANG Yuan-yuan;GONG Xing-chu(College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Innovation Institute for Artificial Intelligence in Medicine of Zhejiang University,Hangzhou 310018,China;College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;Laboratory for the Creation of Modern Traditional Chinese Medicine,Hangzhou 310058,China)

机构地区：[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

出　　处：《分析测试学报》2024年第11期1735-1744,共10页Journal of Instrumental Analysis

基　　金：浙江省科技计划项目(2022C03142)。

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。In this work,a high performance liquid chromatography-diode array detector(HPLCDAD)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 

分 类 号：O657.7[理学—分析化学] R282[理学—化学]