ArticleArchiv der Pharmazie2026
An Ultra-Fast UPLC-MS/MS Method for Quantifying Ivosidenib: Application to Assessment of Metabolic Stability in Human Liver Microsomes.
Article in Archiv der Pharmazie, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Ivosidenib (Tibsovo) is a groundbreaking, first-in-class medication that specifically and reversibly blocks isocitrate dehydrogenase (IDH1), earning multiple FDA approvals for cancers harboring IDH1 mutations. This research developed a rapid, dependable, and sensitive UPLC-MS/MS technique to assess the metabolic stability of ivosidenib (IVB) in human liver microsomes (HLM). The method showed a commendable environmental profile (ComplexMoGAPI score: 69.0, AGREEprep: 0.68, and AGSA: 72.22). Using StarDrop software (including DEREK and P450 tools), chemical structure alerts were detected, and in silico analysis of metabolic vulnerability (CSL value) was conducted. A straightforward isocratic mobile phase system with a stationary phase (C8 column) efficiently separated IVB and baricitinib (BCB as internal standard) in an ultra-fast 1-min run at 0.4 ml/min flow rate. The IVB calibration curve showed a linearity over the range 1.0 to 4000 ng/ml. Accuracy and precision during intra- and inter-day assessments in the range of -2.18% to 10.17% and -2.83% to 12.50%, respectively. The current approach uniquely combines HLMs-based metabolic stability assessment with in silico predictions of metabolic soft spots, toxicity, and ADME, along with dual greenness evaluation, all within a single workflow. The in vitro half-life (t
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