Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos.

ABSTRACT: The present study introduces a systematic approach using analytical quality by design (AQbD) methodology for the development of a qualified liquid chromatographic analytical method, which is a challenge in herbal medicinal products due to the intrinsic complex components of botanical sources. The ultra-high-performance liquid chromatography-photodiode array-mass spectrometry (UHPLC-PDA-MS) technique for 11 flavonoids in Genkwa Flos was utilized through the entire analytical processes, from the risk assessment study to the factor screening test, and finally in method optimization employing central composite design (CCD). In this approach, column temperature and mobile solvent slope were found to be critical method parameters (CMPs) and each of the eleven flavonoid peaks' resolution values w

SUBMITTER: Kim MK 

PROVIDER: S-EPMC8185112 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature