Direct quantification of intact FIM in monkey plasma using a selective chromatography-tandem mass spectrometry method: Application in a pharmacokinetic study.

In this study, we successfully developed a simpler LC-MS/MS method for directly quantifying the intact FIM protein in monkey plasma for the first time. The chromatographic separation of FIM was achieved by using an InertSustain Bio C18 column with a mobile phase of acetonitrile containing 0.1% formic acid (A)-water containing 0.1% formic acid (B) at a flow rate of 0.3 mL/min. Good linearity was observed in the concentration range of 5~500 ng/mL (r2 >0.99). The intra- and inter-day precision (expressed as relative standard deviation, RSD) of FIM was 2.30%~12.8% and 7.30%~13.2%, respectively. The intra- and inter-day accuracy (expressed as a relative error, RE) was -12.7%~6.55% and -10.1%~0.892%, respectively. This method was successfully applied for a pharmacokinetic study of the FIM protein in 4 monkeys after subcutaneous administration. PMID: 31656040 [PubMed - as supplied by publisher]
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Tags: Biomed Chromatogr Source Type: research