A highly sensitive HPLC-MS/MS assay method was established to quantify 20(S)-protopanaxadiol (PPD) in human plasma with dexamethasone as an internal standard. The electrospray ion mass spectrometry (ESI-MS) was operated under the multiple reactions monitoring mode (MRM) using positive ion mode. PPD was extracted from 500 mu L plasma samples by liquid-liquid extraction then separated by a C-18 analytical column with gradient elution. The concentration of PPD could be determined by this HPLC-MS/MS method over the range of 0.05-20 ng/mL with the lower limit of quantification (LLOQ) of 0.05 ng/mL. The method was successfully applied to phase Ha clinical trial of Yuxintine (PPD capsule) in which plasma samples of 87 subjects were analyzed following 6 weeks of oral administration of placebo or PPD capsules in 5 different doses. In this study, the measured concentration was linearly related to the oral dosage with R = 0.9901. The minimum and maximum values of measured concentration were 0.06 and 11.60 ng/mL, respectively. In addition, plasma concentrations of PPD in depression patients were reported for the first time in our study. (C) 2016 Elsevier B.V. All rights reserved.
[1]Fudan Univ, Sch Pharm, Dept Pharmaceut Anal, 826 Zhangheng Rd, Shanghai 201203, Peoples R China;
[2]Jinhua Guangfu Tumour Hosp, Dept Pathol, 1296 Huancheng North Rd, Jinhua City 321001, Zhejiang, Peoples R China;
[3]Shanghai Innovat Res Ctr Tradit Chinese Med, Shanghai 201203, Peoples R China
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