Quality Assessment of Medicinal Product and Dietary Supplements Containing <i>Vitex agnus-castus</i> by HPLC Fingerprint and Quantitative Analyses

Abstract

In this study, we aimed to evaluate the quality of 11 products sold in Japan (one medicinal product and 10 dietary supplements) containing/claiming to contain chasteberry extract (fruit of Vitex agnus-castus L.) using HPLC fingerprint (15 characteristic peaks), quantitative determination of chemical marker compounds, and a disintegration test. The HPLC profile of the medicinal product was similar to that of the reference standard of V. agnus-castus fruit dry extract obtained from European Directive for the Quality of Medicines (EDQM), whereas the profiles of some dietary supplements showed great variability, such as different proportions of peaks or lack of peaks. Results of the principal component analysis of the fingerprint data were consistent with those of the HPLC profile analysis. The contents of two markers, agnuside and casticin, in dietary supplements showed wide variability; this result was similar to that achieved with the HPLC fingerprint. In particular, agnuside and/or casticin was not detected in two dietary supplements. Furthermore, one dietary supplement was suspected to be contaminated with V. negundo, as evidenced from the results of agnuside to casticin ratio and assay of negundoside, a characteristic marker of V. negundo. Results of the disintegration test showed poor formulation quality of two dietary supplements. These results call attention to the quality problems of many dietary supplements, such as incorrect or poor-quality origin, different contents of the active ingredient, and/or unauthorized manufacturing procedures.

Phenolic Compound Analysis and Pharmacological Screening of Vitex agnus-castus Functional Parts

“…Moreover, the chemical analysis by HPLC-MS was identified 11 types of flavonoids; the most abundant is luteolin with high levels especially in the flower part with a value of 77047:5 ± 4006:47 μg/kg. Importantly, other previous studies have also revealed numerous phenolic compounds in V. agnus castus extracts [6,[19][20][21]. Indeed, the rate of phenolic compounds found in our results is not exactly similar to those identified in these reposted works.…”

Does Vitex Agnus-Castus L. Have Deleterious Effect on Fertility and Pregnancy Outcome? An Experimental Study on Rats for Prediction of Its Safety

“…To overcome this gap, patient and healthcare education should be facilitated to provide safe recommendations for VAC use [ 6 ]. Besides, the effects may be influenced by the cultivation region differences in soil, weather, and altitude, the quality of the active prepared herb, and the incorrect or poor quality manufacturing process [ 28 ]. In addition, the type of the nanobarrier used in the VAC extract could potentially impact the oral bioavailability of the drug [ 29 ].…”

Vitex agnus-castus: Botanical features and area, chemical composition of fruit, pharmacological properties, and medicinal uses

“…The dominant flavonoids are casticin and luteolin-7-glycoside. The other compounds present are luteolin , 3,3′-dihydroxy-5,6,7,4′-tetramethoxyflavone, 3,7-dimethylquercetin, 3-O-methylkaempferol, 3-hydroxy-5,6,7,4-tetramethoxyflavone, 3-methylquercetin, 3-methylkaempferol, 5,3′,5′-trihydroxymethoxyflavanone, 5,7,3′,5′-tetrahydroxyflavanone, apigenin, artemetin, vitexin, orientin, isovitexin, isoorientin, kaempferol, penduletin, and eupatorin (Chen et al, 2011;Choudhary et al, 2009;Hajdú et al, 2007;Makhmoor and Choudhary, 2010;Mari et al, 2015;Sogame et al, 2019;Sorensen and Katsiotis, 1999).…”

“…Some other compounds with phenolic structure have been identified. These are 3,4-dihydroxybenzoic acid, 5-hydroxy-2-methoxybenzoic acid, vanillic acid, caffeic acid, ferulic acid, p-hydroxybenzoic acid, p-hydroxyphenylethanol-p-coumarate, myzodendrone, chlorogenic acid, methylisovanillate, and methyl 3,4-dihydroxybenzoate (Chen et al, 2011;Choudhary et al, 2009;Kuruüzüm-Uz et al, 2003;Li et al, 2013;Makhmoor and Choudhary, 2010;Şarer et al, 2008;Sogame et al, 2019).…”