Affordable Access

deepdyve-link
Publisher Website

Development of an HPLC-MS method for the determination of four terpene trilactones in Ginkgo biloba leaf extract via quality by design.

Authors
  • Zhang, Sijie1
  • Wu, Linlin1
  • Wang, Xiaoping1
  • Gong, Xingchu1
  • Qu, Haibin1
  • 1 Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China. , (China)
Type
Published Article
Journal
Biomedical Chromatography
Publisher
Wiley (John Wiley & Sons)
Publication Date
May 13, 2021
Identifiers
DOI: 10.1002/bmc.5170
PMID: 33982313
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Previously reported HPLC-evaporative light scattering detection methods for terpene trilactone determination in Ginkgo biloba leaf extract (EGBL) have complicated sample preparation steps and are time-consuming. Thus, in this work, an HPLC-MS method for the determination of terpene trilactones in EGBL was developed with a novel analytical quality by design approach to provide robust and simple measurements. For this purpose, analytical target profiles and systematic risk analyses were performed to identify potential critical method attributes and critical method parameters. After screening experiments, a Box-Behnken design approach was utilized to investigate the relationships between critical method attributes and critical method parameters. A hypercube design space obtained by a Monte Carlo method was used for choosing the analytical control strategy. Then, verification experiments were performed within the design space, and the models were found to be accurate. After that, the optimized method was verified and successfully used for quality control analysis of EGBL from different manufacturers, and the results were almost the same as those determined by HPLC-evaporative light scattering detection. To our knowledge, this is the first study to establish a robust HPLC-MS method for determination of terpene trilactones in EGBL based on a novel analytical quality by design concept, which can improve the quality control of commercial EGBL. © 2021 John Wiley & Sons, Ltd.

Report this publication

Statistics

Seen <100 times