Natural Product Sciences

The Korean Society of Pharmacognosy (한국생약학회)
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Analytical Quality by Design Methodology Approach for Simultaneous Quantitation of Paeoniflorin and Decursin in Herbal Medicine by RP-HPLC Analysis

  • Kim, Min Kyoung (College of Pharmacy, Kyung Hee University) ;
  • Park, Geonha (Department of Life and Nanopharmaceutical Sciences, Graduate school, Kyung Hee University) ;
  • Hong, Seon-Pyo (Department of Oriental Pharmaceutical Science, College of Pharmacy, Kyung Hee University) ;
  • Jang, Young Pyo (Department of Life and Nanopharmaceutical Sciences, Graduate school, Kyung Hee University)
  • Received : 2021.11.17
  • Accepted : 2021.12.19
  • Published : 2021.12.31
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Abstract

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 ㎛ 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- 25℃; 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.

Keywords

Acknowledgement

This study was funded by a grant (21173MFDS561) from the Ministry of Food and Drug Safety in 2021.

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