Mass spectrometry
LC-MS/MS assay and microsomal half-life of pemigatinib
Open access · cc by · source: Europe PMC
A two-minute LC-MS/MS method quantifies pemigatinib in human liver microsomes and finds a 27.29 min half-life and moderate CLint.
Study at a glance
- Design
- Other — Validated C18 MRM LC-MS/MS of pemigatinib in human liver microsomes with well-stirred clearance model
- N
- Bioanalytical method validation and in-vitro HLM kinetics — no subject N
- Population
- Human liver microsome incubations of pemigatinib
- Outcome
- Quantification performance and in-vitro t½ / CLint of pemigatinib
Structured fields used in claim comparison tables when every cited study has a complete layer.
Key findings
Mean recovery is 101.7 ± 4.48%. In vitro t1/2 is 27.29 min and CLint is 25.4 μL min−1 mg−1, implying moderate hepatic extraction rather than ultra-rapid clearance.
Methodology
Authors developed a C18 MRM method (pemigatinib 488→401/186, flavopiridol IS), validated QCs at 5–400 ng mL−1 after ACN precipitation from HLM, and used an in vitro t1/2 well-stirred model for clearance.
Limitations
No patient pharmacokinetic curves; HLM t1/2 is an in vitro predictor, and the authors note in vivo TDM still needs future work.
How this study connects
Role on claims
Each row is a claim on a concept or method page where this paper supports, challenges, or qualifies the statement. Roles are hand-checked — not a model guess.
A validated C18 MRM LC–MS/MS method (pemigatinib 488→401/186, flavopiridol IS) after acetonitrile precipitation from human liver microsomes has mean recovery 101.7 ± 4.48% with QCs at 5–400 ng mL⁻¹. In vitro t½ is 27.29 min and CLint is 25.4 μL min⁻¹ mg⁻¹, implying moderate hepatic extraction. No patient PK curves are reported.
Evidence for the claim as stated.
Agreement with HPLC-UV recoveries does not mean the new assay is HPLC. The Ag/Au cluster probe matches 94–106% recoveries in 1.5 min but cannot speciate mixed FQs, which a chromatographic method is built to do. Pemigatinib LC–MS/MS recovery 101.7% is a validated concentration assay in HLM, not a 1.5 min optical screen.
Evidence for the claim as stated.
Open questions
Tensions this paper is part of
From concept pages' “where studies disagree.” Disagreement means the same question; scope means different assays, populations, or outcomes.
Agreement with HPLC-UV recoveries does not mean the new assay is HPLC. The Ag/Au cluster probe matches 94–106% recoveries in 1.5 min but cannot speciate mixed FQs, which a chromatographic method is built to do. Pemigatinib LC–MS/MS recovery 101.7% is a validated concentration assay in HLM, not a 1.5 min optical screen.
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Same topic cluster — not a recommendation engine.