title: Development and validation of an LC-MS/MS method for determination of compound K in human plasma and clinical application.
abstract: A rapid, sensitive and selective analytical method was developed and validated for the determination of compound K, a major intestinal bacterial metabolite of ginsenosides in human plasma. Liquid-liquid extraction was used for sample preparation and analysis, followed by liquid chromatography tandem spectrometric analysis and an electrospray-ionization interface. Compound K was analyzed on a Phenomenex Luna C18 column (100×2.00 mm, 3 μm) with the mobile phase run isocratically with 10 mM ammonium acetate-methanol-acetonitrile (5:47.5:47.5, v/v/v) at a flow rate of 0.5 mL/min. The method was validated for accuracy (relative error <12.63%), precision (coefficient of variation <9.14%), linearity, and recovery. The assay was linear over the entire range of calibration standards i.e., a concentration range of 1 ng/mL to 1,000 ng/ mL (r (2) >0.9968). The recoveries of compound K after liquid-liquid extraction at 1, 2, 400, and 800 ng/mL were 106.00±0.08%, 103.50±0.19%, 111.45±5.21%, and 89.62±34.46% for intra-day and 85.40±0.08%, 94.50±0.09%, 112.50±5.21%, and 95.87±34.46% for inter-day, respectively. The lower limit of quantification of the analytical method of compound K was 1 ng/ mL in human plasma. The developed method was successfully applied to a pharmacokinetic study of compound K after oral administration in ten of healthy human subjects.
authors.affiliation: Biomedical Research Institute of Chonbuk National University Hospital, Jeonju 561-712, Korea ; Department of Pediatrics, Chonbuk National University Medical School, Jeonju 561-180, Korea ; Research Institute of Clinical Medicine, Chonbuk National University, Jeonju 561-712, Korea.
authors.forename: Jung Soo
authors.initials: JS
authors.lastname: Kim
authors.forename: Yunjeong
authors.initials: Y
authors.lastname: Kim
authors.forename: Song-Hee
authors.initials: SH
authors.lastname: Han
authors.forename: Ji-Young
authors.initials: JY
authors.lastname: Jeon
authors.forename: Minho
authors.initials: M
authors.lastname: Hwang
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Im
authors.forename: Jung Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Lee
authors.forename: Soo-Wan
authors.initials: SW
authors.lastname: Chae
authors.forename: Min-Gul
authors.initials: MG
authors.lastname: Kim
keywords: Compound K; Fermented Korean red ginseng; LC-MS/MS; Panax ginseng; Pharmacokinetics