Development of an HPLC–MS method for the determination of four terpene trilactones in Ginkgo biloba leaf extract via quality by design. (24th May 2021)

• Record Type: Journal Article
• Authors: Zhang, Sijie; Wu, Linlin; Wang, Xiaoping; Gong, Xingchu; Qu, Haibin
• Is Part Of: Biomedical chromatography. Volume 35:Number 10(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-05-24
• Subjects: Ginkgo biloba leaf extract -- HPLC–MS -- hypercube design space -- quality by design -- terpene trilactones; Chromatographic analysis -- Periodicals; Biology -- Periodicals; Medicine -- Periodicals; Biology -- Periodicals; Chromatography -- methods -- Periodicals; Medicine -- Periodicals; 543.089
• DOI: 10.1002/bmc.5170
• Languages: English
• ISSNs: 0269-3879

Abstract

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.