ArticleScientific reports2021
Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos.
Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- A Box-Behnken design-assisted RP-HPLC method development and optimization for simultaneous determination of four antiviral drugs in pharmaceutical dosage forms.Scientific reports · 2026Article
- Genkwanin mitigates renal fibrosis by reprogramming profibrotic signaling and restoring TFEB-mediated autophagy.Frontiers in pharmacology · 2026Article
- A hybrid innovation method based on quality by design and agile scrum paradigms for the development of medicinal products.Scientific reports · 2025Article
- Technology Readiness Level Roadmap for Developing Innovative Herbal Medicinal Products.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Analytical quality-by-design (AQbD) approach for comprehensive analysis of bioactive compounds from Citrus peel wastes by UPLC.Analytical and bioanalytical chemistry · 2023Article
- Application of the Analytical Procedure Lifecycle Concept to a QuantitativePharmaceuticals (Basel, Switzerland) · 2023Article
- Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants.Plants (Basel, Switzerland) · 2022Review
- Design of Experiments-Based Optimization of Flavonoids Extraction fromPlants (Basel, Switzerland) · 2022Article
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Authors and funding
6 authors.
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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 were used as critical method attributes (CMAs) through data mining conversion formulas. An optimum chromatographic method in the design space was calculated by mathematical and response surface methodology (RSM). The established chromatographic condition is as follows: acetonitrile and 0.1% formic acid gradient elution (0-13 min, 10-45%; 13-13.5 min, 45-100%; 13.5-14 min, 100-10%; 14-15 min, 10% acetonitrile), column temperature 28℃, detection wavelength 335 nm, and flow rate 0.35 mL/min using C
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