دورية أكاديمية
Bioanalysis of alpelisib using liquid chromatography–tandem mass spectrometry and application to pharmacokinetic study
العنوان: | Bioanalysis of alpelisib using liquid chromatography–tandem mass spectrometry and application to pharmacokinetic study |
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المؤلفون: | Seop Lee, Min-Soo Kim, Jong-Woo Jeong, Jung-woo Chae, Tae-Sung Koo, Han-Joo Maeng, Suk-Jae Chung, Kyeong-Ryoon Lee, Yoon-Jee Chae |
المصدر: | Journal of Analytical Science and Technology, Vol 13, Iss 1, Pp 1-13 (2022) |
بيانات النشر: | SpringerOpen, 2022. |
سنة النشر: | 2022 |
المجموعة: | LCC:Chemistry LCC:Analytical chemistry |
مصطلحات موضوعية: | Alpelisib, Liquid chromatography–tandem mass spectrometry, Method validation, Pharmacokinetics, Chemistry, QD1-999, Analytical chemistry, QD71-142 |
الوصف: | Abstract Alpelisib is the first alpha-specific phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, PI3K catalytic subunit alpha-mutated, advanced, or metastatic breast cancer. Substantial attempts have been made to extend its clinical use to other types of cancer. Analytical methods proven to accurately quantify alpelisib would improve the reliability of the preclinical and clinical data of alpelisib. Therefore, we developed and validated a quantification method based on liquid chromatography–tandem mass spectrometry for alpelisib in mouse and human plasma samples. Alpelisib and an internal standard (IS; enzalutamide) were separated from endogenous substances using an XTerra MS C18 column with a linear gradient of 0.1% formic acid in water and 0.1% formic acid in acetonitrile. Multiple reaction monitoring transitions for alpelisib and the IS were m/z 442.1 > 328.0 and m/z 465.0 > 209.1, respectively. The calibration curve for alpelisib was confirmed to be linear in the range of 1–2000 ng/mL in both mouse and human plasma. The intra- and inter-day accuracy and precision met the acceptance criteria, and no significant matrix effects were observed. Alpelisib was stable under various storage and handling conditions, and the carryover effect was overcome using the injection loop flushing method. We successfully used this assay to study the in vitro metabolic profiles and in vivo pharmacokinetics of alpelisib in mice. Here, to the best of our knowledge, we report for the first time a valid quantitative method for alpelisib in mouse and human plasma, which could aid in providing valuable pharmacokinetic information on alpelisib to increase its clinical availability. |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 2093-3371 |
Relation: | https://doaj.org/toc/2093-3371 |
DOI: | 10.1186/s40543-022-00340-7 |
URL الوصول: | https://doaj.org/article/774a27d49e8047f9a7318a5c2a75099b |
رقم الأكسشن: | edsdoj.774a27d49e8047f9a7318a5c2a75099b |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 20933371 |
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DOI: | 10.1186/s40543-022-00340-7 |