文献类型：期刊文献

英文题名：LC-MS/MS multi-component quantification and PCA-based quality evaluation of Guipi decoction freeze-dried powder with candidate marker identification

作者：Wang, Chang[1,2,3];Yan, Wen[1,3];Fang, Huijun[1,3];Zhang, Chongze[1,3];Song, Jiale[1,3];An, Xingliang[1,3];Zheng, Fuyixuan[3];Wei, Aoxue[3];Li, Wenbin[1,3];Chen, Liping[1,3];Wang, Rong[1,3]

第一作者：Wang, Chang

通信作者：Chen, LP[1];Wang, R[1];Chen, LP[2];Wang, R[2]

机构：[1]Gansu Univ Chinese Med, Coll Pharm, Lanzhou 730000, Gansu, Peoples R China;[2]Lanzhou Univ, Hosp & Clin Med Sch 2, Dept Pharm, Lanzhou 730030, Peoples R China;[3]Chinese Peoples Liberat Army, 940th Hosp Joint Logist Support Force, Dept Pharm, Lanzhou, Peoples R China

第一机构：甘肃中医药大学药学院（西北中藏药协同创新中心办公室）

通信机构：[1]corresponding author), Gansu Univ Chinese Med, Coll Pharm, Lanzhou 730000, Gansu, Peoples R China;[2]corresponding author), Chinese Peoples Liberat Army, 940th Hosp Joint Logist Support Force, Dept Pharm, Lanzhou, Peoples R China.|[1073501e14fb35863569f]甘肃中医药大学药学院（西北中藏药协同创新中心办公室）;[10735]甘肃中医药大学;

年份：2026

外文期刊名：ANALYTICAL METHODS

收录：;EI(收录号：20263121206987);Scopus(收录号：2-s2.0-105046025716);WOS:【SCI-EXPANDED(收录号:WOS:001830218000001)】；

基金：This work was supported by the Innovation Fund Project for College Teachers of Gansu Provincial Department of Education (2025B-024), the Gansu Provincial Major Project (23ZDFA013-5), and the Internal Research Project of the 940th Hospital, Joint Logistics Support Force (2023YXKY001).

语种：英文

外文关键词：Identification (control systems) - Medicinal chemistry - Medicine - Pharmacodynamics - Quality control

摘要：Guipi Decoction (GPD) is a traditional Chinese medicine formula used for insomnia and fatigue, but comprehensive quality evaluation of its freeze-dried powder (GDFP) remains challenging due to the lack of a fully validated multi-component analytical method. In this study, an LC-MS/MS method was developed and validated according to ICH Q2(R2) for simultaneous quantification of 11 markers covering seven herbal materials in GDFP. Target analytes were screened by TOF-MS using a literature-curated in-house ion pair database. The method showed excellent linearity (R-2 >= 0.9935), low LODs (0.026-0.61 ng mL(-1)), a uniform LOQ of 4 ng mL(-1), negligible matrix effects (|ME%| < 15%), and acceptable spike recoveries (86.5-115.1% with RSD < 17.8%). The method was successfully applied to six independently prepared GDFP batches and a commercial Guipi mixture after lyophilization. Principal component analysis (PCA) of eight reliably quantified markers explained 83.2% of total variance, identifying ginsenoside Rg1 (19.3%), ferulic acid (18.6%), and spinosin (17.1%) as the primary contributors to batch-to-batch variation. One-way ANOVA confirmed significant inter-batch differences for ten compounds, with spinosin showing the largest variation (F = 123.46 and p < 0.001). Based on a multi-criteria assessment combining PCA contribution, analytical performance, and reported pharmacological activities, these three compounds are statistically prioritized as candidate quality markers warranting future pharmacodynamic validation. This work provides a chemically robust and statistically validated analytical framework for GDFP quality evaluation.