Qualitative and quantitative study of constituents in Chuanshentong injection based on UHPLC-Q-Exactive Plus Orbitrap HRMS and HPLC-UV
ZHU Xing-yu
ZHANG Xiong-li
LI Hua-liu
CHI Ming-yan
HUANG Yong
ZHENG Lin
XIAO Hai-tao
HE Feng
Abstract：Objective:To systematically analyze the chemical composition of Chuanshentong injection by UHPLC Q-Exactive Plus Orbitrap HRMS and determine the contents of the main chemical components by HPLC-UV.Methods:MS and MS/MS were conducted with electrospray ionization(ESI)in both positive and negative modes.The chemical components in Chuanshentong injection were identified by combining the retention time of the reference substances,mass spectrometry ion information,and comparison of relevant mass spectrometry data in the database and literature.According to its main chemical components,UPLC-UV was used to simultaneously determine the contents of 11 components in different batches of Chuanshentong injection.Results:A total of 43 compounds were identified,including 10 phenolic acids,8 amino acids,11 organic acids,7 phthalides and 7 other compounds,of which 14 components were confirmed by chemical reference standards.The 11 components undergone content determination exhibited strong linear relationship in the measured concentration ranges(r≥0.9995).The precision,stability,and repeatability met the requirements,with an average sample recovery rate of 94.89%～98.74%,and the relative standard deviation(RSD)was 0.52%to 1.53%.Conclusion:The method established in this study is simple,rapid,and accurate,further improves the quality control method of Chuanshentong injection,and provides a scientific basis for the improvement of the quality standard of the preparation.
Keywords：Chuanshentong injectionUHPLC-Q-Exactive Plus Orbitrap HRMSHPLC-UVquality controlcomponent analysiscontent determination
Publication Date：2025-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：11( 2541-2551 )