{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T15:55:37Z","timestamp":1766073337205,"version":"3.48.0"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T00:00:00Z","timestamp":1764460800000},"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":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Fedratinib, a selective Janus kinase 2 (JAK2) inhibitor approved by the FDA for the treatment of myeloproliferative neoplasms, particularly myelofibrosis (MF), has clinical relevance. Despite this, no liquid chromatography\u2013tandem mass spectrometry (LC\u2013MS\/MS) method has been reported for its quantification in biological matrices. This study aimed to develop and validate an LC\u2013MS\/MS method for quantifying fedratinib in mice plasma and assessing its pharmacokinetics. The method employed a Sciex 4500 triple quadrupole mass spectrometer with a Shimadzu LC system in positive ionization mode. Chromatographic separation was achieved using a Phenomenex Kinetex C18 column (2.1\u2009\u00d7\u200950\u2009mm, 5.0\u2009\u03bcm) with a gradient mobile phase of 5\u2009mM ammonium formate in 0.1% formic acid and acetonitrile at a flow rate of 0.8\u2009mL\/min. Telmisartan was used as the internal standard (IS). The method was validated in accordance with USFDA M10 bioanalytical guidelines. Fedratinib and IS were detected at m\/z 525.5\u2009\u2192\u2009468.9 and m\/z 515.2\u2009\u2192\u2009276.0, respectively. The assay demonstrated excellent sensitivity (LLOQ: 0.5\u2009ng\/mL), linearity (0.5 to 1000.0\u2009ng\/mL,\n                    <jats:italic>r<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u2009=\u20090.99), and accuracy (95.80\u2013104.52%). Stability studies confirmed the analyte's integrity across multiple freeze\u2013thaw cycles. The developed LC\u2013MS\/MS method is selective, sensitive, fully validated, and was successfully applied to pharmacokinetic studies.\n                  <\/jats:p>","DOI":"10.1002\/bmc.70285","type":"journal-article","created":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T01:35:23Z","timestamp":1764552923000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Validated LC\u2013MS\/MS Method for the Quantitative Determination and Pharmacokinetic Profiling of Fedratinib (TG101348), an Oral JAK2 Inhibitor, in CD1 Mice Plasma"],"prefix":"10.1002","volume":"40","author":[{"given":"Rajesh Kumar","family":"Boggavarapu","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences Vignan's Foundation for Science, Technology and Research  Guntur Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vishwottam","family":"Kandikere","sequence":"additional","affiliation":[{"name":"Division of Biology Syngene International Limited  Bangalore Karnataka India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2948-4948","authenticated-orcid":false,"given":"Jithendra","family":"Chimakurthy","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences Vignan's Foundation for Science, Technology and Research  Guntur Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms24031987"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1039\/d5ay00513b"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6057"},{"key":"e_1_2_10_5_1","article-title":"Bose's Guide to Ruxolitinib, Fedratinib, Pacritinib, and Momelotinib","author":"Bose P.","year":"2024","journal-title":"Targeted Oncology"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V130.Suppl_1.4993.4993"},{"key":"e_1_2_10_7_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).2022.ICH Harmonised Guideline: M10 Bioanalytical Method Validation and Study Sample Analysis.https:\/\/www.ich.org."},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.12256"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2019000954"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280\u2010020\u201004121\u20100"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2015.1590"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102020\u2010137279"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics14051001"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.626897"},{"key":"e_1_2_10_15_1","unstructured":"U.S. Food and Drug Administration.2018.Bioanalytical Method Validation Guidance for Industry. Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)https:\/\/www.fda.gov."},{"key":"e_1_2_10_16_1","unstructured":"U.S. Food and Drug Administration. n.d.INREBIC (Fedratinib) Prescribing Information. FDA Drug Label."},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102016\u201010\u2010695940"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70285","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T15:49:50Z","timestamp":1766072990000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70285"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,30]]},"references-count":16,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/bmc.70285"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70285","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"type":"print","value":"0269-3879"},{"type":"electronic","value":"1099-0801"}],"subject":[],"published":{"date-parts":[[2025,11,30]]},"assertion":[{"value":"2025-09-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70285"}}