ArticleScientific reports2026
Development of a UPLC-MS/MS method and its application for the pharmacokinetic analysis of regorafenib in rats.
Article in Scientific reports, 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
Regorafenib (REG) is a multikinase inhibitor commonly used in the management of hepatocellular carcinoma, gastrointestinal stromal tumors, and colorectal cancer. Nevertheless, adverse effects or insufficient efficacy appear frequently due to individual variability of plasma concentration of this drug. This work was designed to develop a validated bioanalytical method enabling the accurate quantification of regorafenib (REG) and its metabolites, regorafenib N-oxide (M-2) and N-desmethyl regorafenib N-oxide (M-5), in plasma, and to assess the impact of trametinib (TRA) on their pharmacokinetic profiles. A quantitative detection method for REG, M-2 and M-5 in rat plasma were developed using UPLC-MS/MS, with regorafenib D3 as an internal standard. This method was subsequently applied to pharmacokinetic and drug-drug interaction studies in rats. The method demonstrated good linearity within the range of 50-8000 ng/mL, 25-2500 ng/mL and 25-175 ng/mL, for REG, M-2 and M-5, respectively. Both intra-day and inter-day precisions and accuracy (CV% and bias%) were less than 15%, and the recovery, matrix effect, and stability met EMA guideline. The method demonstrated high effectiveness in the quantitative determination of REG, M-2, and M-5 in rat plasma. Results showed that after administration of TRA, the C
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