{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T02:09:25Z","timestamp":1773281365304,"version":"3.50.1"},"reference-count":7,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,3,17]],"date-time":"2025-03-17T00:00:00Z","timestamp":1742169600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Pirtobrutinib is a Bruton's tyrosine kinase inhibitor used to treat mantle cell lymphoma and chronic lymphocytic leukemia. Pirtobrutinib has a steady\u2010state trough concentration of &gt;\u2009825\u2009ng\/mL, corresponding to a 90% inhibitory concentration of Bruton's tyrosine kinase. Therefore, maintaining stable trough concentrations of pirtobrutinib is clinically important; however, no methods of monitoring pirtobrutinib levels have been developed. In this study, our aim was to develop a method to determine pirtobrutinib levels in human plasma and validate it for therapeutic drug monitoring. Pirtobrutinib and ibrutinib (internal standard) were separated on a reversed\u2010phase column using a mobile phase comprising 0.5% KH<jats:sub>2<\/jats:sub>PO<jats:sub>4<\/jats:sub> (pH\u20094.5) and acetonitrile (52:48, v\/v) at a flow rate of 1.0\u2009mL\/min. Ultraviolet detection was performed at 234\u2009nm. Calibration curves for pirtobrutinib were linear (<jats:italic>r<\/jats:italic><jats:sup>2<\/jats:sup>\u2009=\u20090.9998) in the range of 0.25\u201310\u2009\u03bcg\/mL. The intraday and interday validation coefficients were 0.72%\u20132.86% and 1.29%\u20133.22%, respectively. This study is the first one to develop and validate a method for quantifying pirtobrutinib in human plasma. These findings may support the widespread application of therapeutic drug monitoring for pirtobrutinib.<\/jats:p>","DOI":"10.1002\/bmc.70061","type":"journal-article","created":{"date-parts":[[2025,3,17]],"date-time":"2025-03-17T04:21:06Z","timestamp":1742185266000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["High\u2010Performance Liquid Chromatography\u2013Ultraviolet Assay for the Determination of Pirtobrutinib Levels in a Patient With Mantle Cell Lymphoma"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8826-2296","authenticated-orcid":false,"given":"Yoshito","family":"Gando","sequence":"first","affiliation":[{"name":"Department of Medicinal Therapy Research, Education and Research Unit for Comprehensive Clinical Pharmacy Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0587-0091","authenticated-orcid":false,"given":"Takeo","family":"Yasu","sequence":"additional","affiliation":[{"name":"Department of Medicinal Therapy Research, Education and Research Unit for Comprehensive Clinical Pharmacy Meiji Pharmaceutical University  Tokyo Japan"},{"name":"Department of Pharmacy Tokyo Metropolitan Tama Medical Center  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mari","family":"Shimoda","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Tokyo Metropolitan Tama Medical Center  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masao","family":"Tukada","sequence":"additional","affiliation":[{"name":"Department of Hematology Tokyo Metropolitan Tama Medical Center  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,3,17]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2022018674"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(21)00224\u20135"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2300696"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1039\/d4ra06299j"},{"key":"e_1_2_6_6_1","volume-title":"FDA CDER, CVM; Guidance for Industry: Bioanalytical Method Validation","author":"United States Department of Health and Human Services","year":"2018"},{"key":"e_1_2_6_7_1","unstructured":"United States Food and Drug Administration.2023. \u201cJAYPIRCA\u00ae (Pirtobrutinib) Tablets for Oral Use: Prescribing Information.\u201dhttps:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/216059s001lbl.pdf."},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cbi.2024.111241"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70061","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:45:44Z","timestamp":1760035544000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70061"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,17]]},"references-count":7,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1002\/bmc.70061"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70061","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,17]]},"assertion":[{"value":"2024-12-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70061"}}