{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T17:00:25Z","timestamp":1783443625838,"version":"3.54.6"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>A rapid, simple and highly sensitive stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated for the estimation of asciminib in human plasma. Plasma samples (100\u00a0\u03bcL) were processed by solid-phase extraction. Chromatographic separation was performed using a CAPCELL PAK C18 MGII column (4.6\u2009\u00d7\u2009250\u00a0mm, 5\u00a0\u03bcm); the mobile phase consisted of 0.5% potassium dihydrogen phosphate (KH2PO4, pH\u00a03.5): acetonitrile: methanol (50:45:5, v\/v\/v) at a flow rate of 0.5\u00a0mL\/min. Detection was carried out at a wavelength of 250\u00a0nm. The developed method showed good linearity over the concentration range of 10\u20135000\u00a0ng\/mL (correlation coefficient: 0.9999). The method was then validated according to guidelines published by the US Food and Drug Administration. The coefficients of variation for intra- and interday assays for asciminib were less than 13.9%, whereas accuracies for intra- and interday assays were within 8.9%. The limit of quantification was 10\u00a0ng\/mL. The mean (minimum \u2013 maximum) plasma trough concentration of asciminib in 29 Japanese patients with chronic myeloid leukemia who received repeated administration of 40\u00a0mg twice daily was 367 (101\u2013807) ng\/mL. The validated method can be used as a routine method to support pharmacokinetic studies of asciminib.<\/jats:p>","DOI":"10.1093\/chromsci\/bmaf056","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T15:04:55Z","timestamp":1763737495000},"source":"Crossref","is-referenced-by-count":1,"title":["Development and Validation of a Novel High-Performance Liquid Chromatography Assay with Ultraviolet Detection for Determination of Asciminib in Human Plasma"],"prefix":"10.1093","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7120-2425","authenticated-orcid":false,"given":"Masatomo","family":"Miura","sequence":"first","affiliation":[{"name":"Department of Pharmacokinetics, Akita University Graduate School of Medicine , 1-1-1 Hondo, Akita , 010-8543,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6758-3787","authenticated-orcid":false,"given":"Naoto","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Hematology, Nephrology, and Rheumatology, Akita University Graduate School of Medicine , 1-1-1 Hondo, Akita , 010-8543,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,11,21]]},"reference":[{"key":"2025112110044794200_ref1","doi-asserted-by":"publisher","first-page":"733","DOI":"10.1038\/nature21702","article-title":"The allosteric inhibitor ABL001 enables dual targeting of BCR-ABL1","volume":"543","author":"Wylie","year":"2017","journal-title":"Nature"},{"key":"2025112110044794200_ref2","doi-asserted-by":"publisher","first-page":"8120","DOI":"10.1021\/acs.jmedchem.8b01040","article-title":"Discovery of asciminib (ABL001), an allosteric inhibitor of the tyrosine kinase activity of BCR-ABL1","volume":"61","author":"Schoepfer","year":"2018","journal-title":"Journal of Medicinal Chemistry"},{"key":"2025112110044794200_ref3","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1080\/00498254.2019.1594449","article-title":"Disposition of asciminib, a potent BCR-ABL1 tyrosine kinase inhibitor, in healthy male subjects","volume":"50","author":"Tran","year":"2020","journal-title":"Xenobiotica"},{"key":"2025112110044794200_ref4","doi-asserted-by":"publisher","first-page":"207","DOI":"10.1002\/cpdd.1019","article-title":"Pharmacokinetics of asciminib when taken with imatinib or with food","volume":"11","author":"Hoch","year":"2022","journal-title":"Clinical Pharmacology in Drug Development"},{"key":"2025112110044794200_ref5","doi-asserted-by":"publisher","first-page":"385","DOI":"10.1002\/cpdd.602","article-title":"Relative bioavailability and food effect evaluation for 2 tablet formulations of asciminib in a 2-arm, crossover, 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of Drug and Alcohol Research"},{"key":"2025112110044794200_ref14","doi-asserted-by":"publisher","first-page":"S1138","DOI":"10.1016\/j.arabjc.2013.02.006","article-title":"Development and validation of RP-HPLC method for the estimation of erlotinib in pharmaceutical formulation","volume":"10","author":"Latha","year":"2017","journal-title":"Arabian Journal of Chemistry"},{"key":"2025112110044794200_ref15","volume-title":"Guidance for industry, bioanalytical method validation","author":"US Food and Drug Administration","year":"2018"},{"key":"2025112110044794200_ref16","author":"The Food and Drug Administration, USA, Center for Drug Evaluation and Research","year":"2021"}],"container-title":["Journal of Chromatographic 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