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<p>Bruton’s tyrosine kinase (BTK) inhibitors play a critical role in the treatment of mantle cell lymphoma (MCL). pirtobrutinib, a new, highly selective, non-covalent BTK inhibitor, was approved by the FDA for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). In this study, we established a robust and reliable method for the quantitation of pirtobrutinib in rat plasma using ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS). Acetonitrile and 0.1% formic acid served as the mobile phase, with zanubrutinib as the internal standard (IS). Detection ion transitions were <i>m/z</i> 480.12→294.05 for pirtobrutinib and <i>m/z</i> 472.20→ 289.96 for Zanubrutinib. The intra‐day and inter‐day relative standard deviation (RSD%) values of pirtobrutinib were less than 9.8% and 10.3%, respectively. Recovery and matrix effects ranged from 95.1 to 101.5% and 91.7-100.4%. In addition, the test sample stability was confirmed under various storage conditions, and this method was successfully applied to a pharmacokinetic study of pirtobrutinib at a dose of 10&#xa0;mg·kg<sup>− 1</sup>.</p>

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Development of a novel UHPLC-MS/MS method for quantitative analysis of pirtobrutinib in rat plasma: application to pharmacokinetic study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月22日

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  • Meijuan Zhang,
  • Jingxuan Wu,
  • Jiangshuo Li,
  • Hang Yin,
  • Mengyu Hou,
  • Ruihua Dong

摘要

Bruton’s tyrosine kinase (BTK) inhibitors play a critical role in the treatment of mantle cell lymphoma (MCL). pirtobrutinib, a new, highly selective, non-covalent BTK inhibitor, was approved by the FDA for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). In this study, we established a robust and reliable method for the quantitation of pirtobrutinib in rat plasma using ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS). Acetonitrile and 0.1% formic acid served as the mobile phase, with zanubrutinib as the internal standard (IS). Detection ion transitions were m/z 480.12→294.05 for pirtobrutinib and m/z 472.20→ 289.96 for Zanubrutinib. The intra‐day and inter‐day relative standard deviation (RSD%) values of pirtobrutinib were less than 9.8% and 10.3%, respectively. Recovery and matrix effects ranged from 95.1 to 101.5% and 91.7-100.4%. In addition, the test sample stability was confirmed under various storage conditions, and this method was successfully applied to a pharmacokinetic study of pirtobrutinib at a dose of 10 mg·kg− 1.