Development of a HPLC-PDA Method for Simultaneous Determination of Twelve Marker Compounds of Traditional Korean Medicinal Products

Traditional Korean medicinal product consists of various traditional Korean medicines. Identification and assay are performed to confirm quality of traditional Korean medicinal product. Currently, assay of traditional Korean medicinal product requires a lot of analysis time due to an individual ingredient-specific pretreatment process. So it is necessary to improve it for reasonable quality control in pharmaceutical industry. In this study, we’ve focused on development of the simultaneous assay method with 12 marker compounds, which is applicable to every 87 traditional Korean medicinal products whose dosage form is ‘extract granules’, listed in the Korean Pharmacopoeia (KP) and the Korean Herbal Pharmacopoeia (KHP). The 12 characterizing compounds were amygdalin, geniposide, puerarin, paeoniflorin, hesperidin, 6,7-dimethylesculetin (scoparone), baicalin, berberine hydrochloride, cinnamic acid, paeonol, glycyrrhizic acid and schizandrin. We performed the validation and confirmed linearity, limit of detection, limit of quantitation, accuracy and precision. The R² value of linearity for characterizing compounds was ≥ 0.99, respectively. And the recovery rate was 80~120%, and the RSD was 15% or less. Also, it was confirmed that the contents of characterzing compound were similar comparing newly-developed test method to current test method. As a result, the developed simultaneous analysis methods have been reflected in Korean Herbal Pharmacopoeia and used for the quality control of traditional Korean medicinal products.