Analytical Quality by Design Methodology Approach for Simultaneous Quantitation of Paeoniflorin and Decursin in Herbal Medicine by RP-HPLC Analysis

Min Kyoung Kim; Geonha Park; Seon-Pyo Hong; Young Pyo Jang

doi:10.20307/nps.2021.27.4.264

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한국생약학회
Natural Product Sciences 학술저널
Natural Product Sciences Vol.27 No.4
2021.12 264 - 273 (10page)
DOI : 10.20307/nps.2021.27.4.264

저자정보

Min Kyoung Kim (Kyung Hee University)
Geonha Park (Kyung Hee University)
Seon-Pyo Hong (Kyung Hee University)
Young Pyo Jang (Kyung Hee University)

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Simultaneous quantification of multiple marker compounds in herbal medicine by high performance liquid chromatography (HPLC) analysis is still a challenge due to the complexity in various parameters to be considered and co-existing multi-components. As a case study, a reliable HPLC method for simultaneous quantification of paeoniflorin from Paeoniae Radix and decursin from Angelicae Gigantis Radix in various commercial herbal medicine was developed based on analytical quality by design (AQbD) strategy. As a first step, risk assessment was performed to select the critical method parameters (CMPs) which were decided as organic mobile phase ratio and column oven temperature. In order to evaluate the effect of the CMPs on critical method attributes (CMAs) of peak resolution and tailing, central composite design (CCD) was employed. The final chromatographic conditions were optimized as follows: column- C18, 4.6 × 250 mm, 5 μm particle size; mobile phase- A: acetonitrile, B: 0.1% acetic acid water; detection wavelength- 235 nm for paeoniflorin, 325 nm for decursin; column oven temperature- 25oC; flow rate- 1.0 mL/min; gradient mobile phase system as Time (min) : % A, 0:14, 25:14, 30:50, 60:50, 61:100, 65:100, 66:14, 75:14. The method was successfully validated according to the International Conference on Harmonization (ICH) guidelines and piloted for ten commercial herbal medicines.

#analytical quality by design #simultaneous quantitation #paeoniflorin #decursin #herbal medicine