| DOI: 10.29090/psa.2025.01.24.AB0626 | Pharm Sci Asia 2025; 52(1), 55-64 |
A stability-indicating HPLC method for determination of chemical markers in Boesenbergia rotunda extract capsulesPhatharaphisit Suphakijudomkarn1, Chaweewan Suwanvecho2, Pongtip Sithisarn3, Phisit Khemawoot4, Piyanuch Rojsanga5,*
1 Center of analysis for product quality (Chemical division), Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
2
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
3
Department of Pharmacognosy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
4
Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand
5
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
Boesenbergia rotunda, or krachai in Thai, is a medicinal plant with the potential for medicinal and nutraceutical development because of its pharmacological properties. Therefore, a well-developed and accurate analytical method is crucial to ensure the appropriate quality control of B. rotunda products. This study aimed to develop a simple stability-indicating HPLC-UV method for the quantitative determination of pinocembrin, pinostrobin, and panduratin A contents in B. rotunda extract capsules. HPLC chromatographic conditions were optimized using a C18 column. The mobile phase comprised of 0.1% formic acid in water and methanol in acetonitrile using a gradient system at a flow rate of 1 mL/min. The detection wavelength was 300 nm. The method was validated according to the guidelines of the International Conference on Harmonization (ICH Q2) for linearity, accuracy, precision, and specificity. Forced degradation studies under acid, base, oxidation, and sun photolytic conditions were also performed. The forced degradation of B. rotunda extract capsule showed that all selected chemical constituents were stable in acid and oxidative conditions, but they were highly labile under basic and photolytic conditions. There was no interference from impurities, degradation products, or excipients in the HPLC chromatogram at the retention times of those standards indicating the specificity of the analytical method. The developed HPLC method promoted linear correlations in the range of 10-200 µg/mL for pinocembrin, 50-1000 µg/mL for pinostrobin, and 5-100 µg/mL for panduratin A, with correlation coefficients (r) > 0.99. The recoveries were acceptable for all markers. Relative standard deviations (RSDs) of repeatability and intermediate precision were less than 2.0%. HPLC method has been successfully developed and validated for quantitative analysis of chemical markers in B. rotunda extract capsules. This study provides a promising chemical analysis approach for quality control and standardization of herbal medicines, especially B. rotunda products in the future.
Keyword:
HPLC; stability indicating method; Boesenbergia rotunda; pinocembrin; pinostrobin; panduratin A
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