Evidence map›Paper›PMID 42544568›Full record

ArticleBioanalysis2026

Development and validation of a sensitive HPLC-MS/MS method for the analysis of semaglutide in human plasma.

Christopher Tudan, Joel Stickling, Emily Northwick Darden, Lauren Devine, Shane Needham

Abstract readValidation Study
In one paragraph

Article in Bioanalysis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Christopher TudanDepartment of Bioanalysis, Veloxity Labs, LLC, Peoria, IL, USA.
Joel SticklingDepartment of Bioanalysis, Veloxity Labs, LLC, Peoria, IL, USA.
Emily Northwick DardenDepartment of Bioanalysis, Veloxity Labs, LLC, Peoria, IL, USA.
Lauren DevineDepartment of Bioanalysis, Veloxity Labs, LLC, Peoria, IL, USA.
Shane NeedhamDepartment of Bioanalysis, Veloxity Labs, LLC, Peoria, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSemaglutide is a human glucagon-like peptide-1 (GLP-1) peptide analog. To date, the literature does not report a validated HPLC-MS/MS assay using a triple-quadrupole mass spectrometer for the quantitation of semaglutide in human plasma in support of pharmacokinetics. A robust, sensitive HPLC--MS/MS assay supporting this class of compounds, is provided and full validation demonstrated. METHODS AND

resultsA triple-quadrupole HPLC-MS/MS method has been developed and fully validated for the quantitation of semaglutide in human plasma, using a stable isotope labeled internal standard and an effective, efficient protein precipitation sample extraction. The method has a sensitive analytical range of 5 ng/mL to 200 ng/mL (and to 1000 ng/mL with a dilution QC) and exhibits excellent accuracy (92.7% to 109.4%) and precision of <10.6%. This highly selective method provided high recovery of the analyte, with minimal matrix effects.

conclusionA robust and simple HPLC-MS/MS method to quantify semaglutide in human plasma has been fully validated in accordance with the 2022 FDA M10 guidance. This method is suitable for implementation in clinical studies within the validated analytical range and stability conditions and can be extended to the bioanalysis of other GLP-1 peptide-based therapeutics with similar structural and physiochemical properties.

Indexed as

Glucagon-Like PeptidesLiquid Chromatography-Mass SpectrometryTandem Mass SpectrometryChromatography, High Pressure LiquidHumansLimit of DetectionSemaglutideGlucagon-Like PeptidesSemaglutideGLP-1HPLC-MS/MSICH M10method validationpeptidessemaglutide

Identifiers

PMID42544568
PMCPMC13540083

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.