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 qualified liquid chromatographic method, which is challenge in herbal medicinal products due to intrinsic complex components botanical sources. ultra-high-performance chromatography-photodiode array-mass spectrometry (UHPLC-PDA-MS) technique 11 flavonoids Genkwa Flos was utilized through entire processes, from risk assessment factor screening test, and finally method optimization employing central composite (CCD). In this approach, column temperature mobile solvent slope were found be critical parameters (CMPs) each eleven flavonoid peaks’ resolution values used as attributes (CMAs) data mining conversion formulas. An optimum space calculated mathematical response surface (RSM). established condition follows: acetonitrile 0.1% formic acid gradient elution (0–13 min, 10–45%; 13–13.5 45–100%; 13.5–14 100–10%; 14–15 10% acetonitrile), 28?, detection wavelength 335 nm, flow rate 0.35 mL/min C 18 (50 × 2.1 mm, 1.7 ?m) column. A validation also performed successfully apigenin 7- O -glucuronide, apigenin, genkwanin. few important results linearity over 0.999 coefficient correlation, limit 2.87–22.41, quantitation 8.70–67.92, relative standard deviation precision less than 0.22%, accuracy between 100.13 102.49% genkwanin, -glucuronide. conclusion, design-based provide platform that can effectively applied ensure pharmaceutically natural based drug.