Pharmacokinetic samples were obtained at seven time points: Baseline (before and 1 h after infusion), day 28 (before and 1 h after infusion), day 56 (before and 1 h after infusion), and at the end of the study (day 98). PK plasma samples with lithium heparinate as anticoagulant were collected and stored at ~ − 20 °C and analyzed after the study by Farmovs Integrated Research Solutions in Bloemfontein, South Africa. Extraction from the biological matrix was performed with a protein precipitation technique, liquid chromatography with tandem mass spectrometry detection (LC–MS/MS) Sciex API4000. The software used Watson LIMS™ software version 7.4.2 and Analyst® software version 1.6.2.
Sciex api4000
Manufactured by AB Sciex
The Sciex API4000 is a tandem mass spectrometry system designed for quantitative and qualitative analysis of small molecules. It features a triple quadrupole configuration for high-sensitivity detection and reliable performance.
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Lab products found in correlation
2 protocols using sciex api4000
1
Pharmacokinetic Sampling and Analysis
2
Edoxaban Plasma Pharmacokinetics Analysis
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Free-base plasma concentrations of edoxaban were analyzed by Advion BioServices using a liquid chromatography separation with a tandem mass spectrometer detection method. Analytes and standards were isolated from a 200 μL plasma sample using Oasis MCX™ (mixed mode cation exchange resin) 96-well solid-phase extraction plates (Waters Corporation, Milford, MA). Analysis of extracted samples was performed by gradient chromatography using a Zorbax Eclipse XDB Phenyl (50 mm x 2.1 mm, 5 μm; Agilent Technologies, Santa Clara, CA) column. Analytes and standards were detected using a Sciex API 4000 triple quadrupole spectrometer (Sciex, Framingham, MA) with TurboIonSpray source (Sciex) in positive ionization mode. Edoxaban was quantified using a quadratic (1/X 2 weighting) calibration curve ranging from 0.764 to 382 ng/mL. PK parameters were calculated from the individual plasma concentrations of edoxaban using a noncompartmental approach. The parameters measured include the area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0 -inf ), the maximum (peak) observed concentration in plasma (C max ), the time of maximum observed concentration (T max ), and the apparent terminal half-life (T 1/2 ).
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