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Therefore, the objective of this study was to develop and validate a rapid LC\u2010MS\/MS analytical method for the simultaneous determination of cobicistat and venetoclax concentrations in plasma and serum. The method was validated according to EMA and FDA guidelines. Chromatographic separation was performed using a liquid chromatography (LC) system with a C18 column. The elution gradient involved two mobile phases: mobile phase A (ammonium formate) and mobile phase B (acetonitrile). The concentration range was 5\u2013500\u2009\u03bcg\/L for cobicistat and 50\u20135000\u2009\u03bcg\/L for venetoclax. Accuracy and precision were within the required limits, with accuracy ranging from \u22125.9% to 2.4%, within\u2010day precision from 1.2% to 4.8%, and between\u2010day precision from 0.4% to 4.3%. Cobicistat and venetoclax were stable for at least 8\u2009days under various storage and handling conditions. Clinical TDM samples showed mean concentrations \u00b1 standard deviation (SD) of 138.8\u2009\u00b1\u2009123.3\u2009\u03bcg\/L for cobicistat and 1497.1\u2009\u00b1\u20091285.9\u2009\u03bcg\/L for venetoclax. The development and validation of this LC\u2010MS\/MS assay provide a reliable and efficient method for the simultaneous quantification of cobicistat and venetoclax in plasma and serum samples.<\/jats:p>","DOI":"10.1002\/bmc.70179","type":"journal-article","created":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T01:44:32Z","timestamp":1753753472000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Validation of a LC\u2010MS\/MS Assay for Rapid and Simultaneous Quantification of Cobicistat and Venetoclax in Human Plasma and Serum"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3370-1618","authenticated-orcid":false,"given":"Niels","family":"Westra","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen University of Groningen  Groningen The 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