دورية أكاديمية

Bioanalysis of alpelisib using liquid chromatography–tandem mass spectrometry and application to pharmacokinetic study

التفاصيل البيبلوغرافية
العنوان: Bioanalysis of alpelisib using liquid chromatography–tandem mass spectrometry and application to pharmacokinetic study
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
الوصف
تدمد:20933371
DOI:10.1186/s40543-022-00340-7