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 source...

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Autores principales:	Min Kyoung Kim, Sang Cheol Park, Geonha Park, Eunjung Choi, Yura Ji, Young Pyo Jang
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/eb2010c9bf3a4aad98b7f1967d91afd3
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spelling	oai:doaj.org-article:eb2010c9bf3a4aad98b7f1967d91afd32021-12-02T17:52:32ZAnalytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos10.1038/s41598-021-91341-w2045-2322https://doaj.org/article/eb2010c9bf3a4aad98b7f1967d91afd32021-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-91341-whttps://doaj.org/toc/2045-2322Abstract 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 C18 (50 × 2.1 mm, 1.7 μm) column. A validation study was also performed successfully for apigenin 7-O-glucuronide, apigenin, and genkwanin. A few important validation results were as follows: linearity over 0.999 coefficient of correlation, detection limit of 2.87–22.41, quantitation limit of 8.70–67.92, relative standard deviation of precision less than 0.22%, and accuracy between 100.13 and 102.49% for apigenin, genkwanin, and apigenin 7-O-glucuronide. In conclusion, the present design-based approach provide a systematic platform that can be effectively applied to ensure pharmaceutically qualified analytical data from complex natural products based botanical drug.Min Kyoung KimSang Cheol ParkGeonha ParkEunjung ChoiYura JiYoung Pyo JangNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Min Kyoung Kim Sang Cheol Park Geonha Park Eunjung Choi Yura Ji Young Pyo Jang Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos
description	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 C18 (50 × 2.1 mm, 1.7 μm) column. A validation study was also performed successfully for apigenin 7-O-glucuronide, apigenin, and genkwanin. A few important validation results were as follows: linearity over 0.999 coefficient of correlation, detection limit of 2.87–22.41, quantitation limit of 8.70–67.92, relative standard deviation of precision less than 0.22%, and accuracy between 100.13 and 102.49% for apigenin, genkwanin, and apigenin 7-O-glucuronide. In conclusion, the present design-based approach provide a systematic platform that can be effectively applied to ensure pharmaceutically qualified analytical data from complex natural products based botanical drug.
format	article
author	Min Kyoung Kim Sang Cheol Park Geonha Park Eunjung Choi Yura Ji Young Pyo Jang
author_facet	Min Kyoung Kim Sang Cheol Park Geonha Park Eunjung Choi Yura Ji Young Pyo Jang
author_sort	Min Kyoung Kim
title	Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos
title_short	Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos
title_full	Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos
title_fullStr	Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos
title_full_unstemmed	Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos
title_sort	analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in genkwa flos
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/eb2010c9bf3a4aad98b7f1967d91afd3
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Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos

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