Academic Journal

Development and validation of an ultra‐performance liquid chromatography–tandem mass spectrometry method to quantify the small molecule inhibitors adagrasib, alectinib, brigatinib, capmatinib, crizotinib, lorlatinib, selpercatinib, and sotorasib in human plasma

التفاصيل البيبلوغرافية
العنوان: Development and validation of an ultra‐performance liquid chromatography–tandem mass spectrometry method to quantify the small molecule inhibitors adagrasib, alectinib, brigatinib, capmatinib, crizotinib, lorlatinib, selpercatinib, and sotorasib in human plasma
المؤلفون: Hollander, Esther M., Zimmerman, Nachel M. C., Piet, Berber, van den Heuvel, Michel M., Burger, David M., te Brake, Lindsey H. M., ter Heine, Rob
المساهمون: Amgen
المصدر: Biomedical Chromatography ; ISSN 0269-3879 1099-0801
بيانات النشر: Wiley
سنة النشر: 2024
المجموعة: Wiley Online Library (Open Access Articles via Crossref)
الوصف: Small molecule inhibitors (SMIs) are increasingly being used in the treatment of non‐small cell lung cancer. To support pharmacokinetic research and clinical treatment monitoring, our aim was to develop and validate an ultra‐performance liquid chromatography–mass spectrometry (UPLC‐MS/MS) assay for quantification of eight SMIs: adagrasib, alectinib, brigatinib, capmatinib, crizotinib, lorlatinib, selpercatinib, and sotorasib. Development of the UPLC‐MS/MS assay was done by trying different columns and eluents to optimize peak shape. The assay was validated based on guidelines of the European Medicines Agency. Chromatographic separation was performed with a gradient elution using ammonium formate in water and methanol. Detection was performed using a triple quadrupole tandem mass spectrometer with electrospray ionization. Validation was performed in a range of 10–2500 μg/L for lorlatinib, 25–6250 μg/L for alectinib and crizotinib, 25–10,000 μg/L for capmatinib and selpercatinib, 50–12,500 μg/L for brigatinib, and 100–25,000 μg/L for adagrasib and sotorasib. Imprecision was <8.88% and inaccuracy was <12.5% for all compounds. Seven out of eight compounds were stable for 96 h at room temperature. Sotorasib was stable for 8 h at room temperature. A sensitive and reliable method has been developed to quantify eight SMIs with a single assay, enhancing efficacy and safety of targeted therapies.
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1002/bmc.5986
الاتاحة: http://dx.doi.org/10.1002/bmc.5986
Rights: http://creativecommons.org/licenses/by-nc-nd/4.0/
رقم الانضمام: edsbas.F2FFB5A7
قاعدة البيانات: BASE