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- Title
Determination of Bulleyaconitine A in Human Plasma by HPLC-MS/MS and Its Bioequivalence Study.
- Authors
Li Xiang-Hong; Sun Hua; Jia Yuan-Wei; Zhou Li-Xiang; Wang Wei-Jia; Dai Min; Zhao Ya-Nan; Xie Hai-Tang
- Abstract
A high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) method was developed and validated for the determination of Bulleyaconitine A (BLA) in human plasma using carbamazepinum as internal standard (IS). Plasma samples were extracted with Waters Oasis HLB solid-phase cartridges, separated on a reversed C18 column (150 mm x 4.6 mm, 5 µm) with a mobile phase of methonal - 10 mmol/L ammonium acetate solution containing 0.1% formic acid (85: 15, v/v). Bulleyaconitine A and IS were detected in the multiple reaction monitoring mode (MRM) with precursor to product ion transitions of m/z 644.4/584.4 and 237.2/194.2, respectively. The method exhibited a linear range of 0. 010-1.0 ng/mL for BLA in human plasma. The lowest limit of quantification (LLOQ) was 0.010 ng/mL, which was sensitive enough for the pharmacokinetic study of BLA. Acceptable precision and accuracy were obtained for concentrations of the calibration standard and the quality control (QC). The validated method was successfully applied for evaluation of a bioequivalence study in Chinese healthy volunteers. The main pharmacokinetics parameters after oral administration of 0.4 mg BLA test or reference formulation were as follows: Cmax(0.325 ± 0.110), (0.323 ± 115) ng/mL;AUC0-16 (1.627 ± 0.489), (1.732 ± 0.556) ng ⋅ h/mL; AUC0-∞ (1. 730 ± 0.498), (1.831 ± 0.562) ng ⋅ h/mL; t1/2 (4.26 ± 0.95), (3.80 ± 0.90) h;Tmax (1.34 ± 0.54), (1.83 ± 0.99) h.
- Subjects
HIGH performance liquid chromatography; ALKALOIDS; THERAPEUTIC equivalency in drugs; BLOOD plasma; ELECTROSPRAY ionization mass spectrometry; CARBAMAZEPINE; PHARMACOKINETICS; AMMONIUM acetate
- Publication
Natural Product Research & Development, 2011, Vol 23, Issue 6, p1031
- ISSN
1001-6880
- Publication type
Article