Ultra-sensitive bioanalysis of the therapeutic peptide exenatide for accurate pharmacokinetic analyses at effective plasma concentrations utilizing UPLC-MS/MS

Publication date: Available online 22 February 2020Source: Journal of Pharmaceutical AnalysisAuthor(s): Max Sauter, Philipp Uhl, Jürgen Burhenne, Walter E. HaefeliAbstractExenatide is the first approved glucagon-like peptide 1 receptor agonist subcutaneously or intramuscularly injected for the treatment of type 2 diabetes mellitus. Typical therapeutic plasma concentrations are in the low pg/mL range therefore requiring ultra-sensitive quantification. To enable the accurate evaluation of pharmacokinetic studies, we established a UPLC-MS/MS assay with a lower limit of quantification (LLOQ) of 5 pg/mL (1.2 pM) using 200 μL of plasma, validated according to FDA's and EMA's pertinent guidelines. Exenatide was isolated from plasma with solid phase extraction utilizing anion-exchange sorbent. Quantification was performed with positive electrospray ionization tandem mass spectrometry in the selected reaction monitoring mode. The calibrated concentration range of 5–10,000 pg/mL was linear showing correlation coefficients>0.99. Interday and intraday accuracy ranged from 97.5 to 105.4% with corresponding precision of
Source: Journal of Pharmaceutical Analysis - Category: Drugs & Pharmacology Source Type: research

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