BioNotus GCV, Niel, Belgium.
BioNotus GCV, Niel, Belgium.
J Pharmacol Toxicol Methods. 2023 Sep-Oct;123:107264. doi: 10.1016/j.vascn.2023.107264. Epub 2023 Mar 22.
The IMI project ConcePTION was launched to fill the knowledge gap of using medicines during pregnancy and lactation. To achieve this goal, several studies are being conducted, including the bioanalysis of amoxicillin in minipig plasma and milk. A high-throughput, robust and reliable liquid chromatography tandem mass spectrometry method was developed and validated according to FDA and EMA guidelines to determine the concentrations of amoxicillin in a large number of minipig plasma and milk samples. Chromatographic separation was achieved on a Luna® Omega Polar C18, 1.6 μm, 100 × 2.1 mm column, with a mobile phase consisting of 0.1% formic acid in water and acetonitrile. Mass spectrometry used in a positive ionization mode and the transitions m/z 366.1 → 349.2 was selected to monitor amoxicillin, while m/z 370.1 → 114.15 was selected for the stable isotope labelled internal standard. This method features a linear quantification range of 10 ng/mL - 10 μg/mL, recovery of not less than 94.1%, a single sample extraction method for both plasma and milk matrices, and an analysis runtime of 5 min.
IMI 项目 ConcePTION 的启动是为了填补孕期和哺乳期用药知识的空白。为了实现这一目标，正在进行多项研究，包括在迷你猪血浆和乳中进行阿莫西林的生物分析。根据 FDA 和 EMA 的指南，开发并验证了一种高通量、稳健且可靠的液相色谱串联质谱法，以确定大量迷你猪血浆和奶样中的阿莫西林浓度。采用 Luna® Omega Polar C18、1.6μm、100×2.1mm 柱进行色谱分离，流动相由水中 0.1%甲酸和乙腈组成。质谱采用正离子化模式，监测阿莫西林的离子 m/z 366.1→349.2，选择 m/z 370.1→114.15 作为稳定同位素标记内标。该方法的线性定量范围为 10ng/mL-10μg/mL，回收率不低于 94.1%，适用于血浆和乳基质的单一样品提取方法，分析时间为 5 分钟。
