化学
生物分析
色谱法
分析物
蛋白质沉淀
样品制备
定量分析(化学)
人血浆
检出限
选择性反应监测
质谱法
萃取(化学)
液相色谱-质谱法
校准曲线
作者
Samantha Franzoni,Lisa Morbioli,Antonio Turtoro,Lara Solazzo,Alessandro Greco,Mariamena Arbitrio,Pierosandro Tagliaferri,Pierfrancesco Tassone,Maria Teresa Di Martino,M. Breda
标识
DOI:10.1016/j.jpba.2020.113451
摘要
LNA-i-miR-221, a 13-mer oligonucleotide, has proved favorable efficacy and safety profiles in the preclinical studies, leading to being approved for use in clinical trials by regulatory authorities. The objective of this study was to develop and validate LC-MS/MS methods to quantify LNA-i-miR-221 in human plasma and urine. Chromatographic separation was performed with a gradient system on HALO C18 column using hexafluoro-2-propanol/triethylamine buffer and methanol as mobile phase. LNA-i-miR-221 was detected on tandem mass spectrometer with electrospray ionization source in negative ion mode. The methods showed good linearity within the calibration range of 50-25000 ng/mL and 50-50000 ng/mL for human plasma and urine, respectively. The methods proved to be accurate, precise and selective in both human matrices. These validated methods are reliable and are currently in use to support a first-in-human clinical trial of LNA-i-miR-221 in patients affected by refractory multiple myeloma and advanced solid tumors.
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