Determination of Nifuratel in Human Plasma by Using Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Pharmacokinetic Study

In this study, a rapid, straightforward, and sensitive method was developed and validated for the quantification of nifuratel (NIF) in human plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Plasma samples were processed using liquid-liquid extraction with nifuratel 13C D3 as the internal standard (IS). Chromatographic separation was achieved on a Waters ACQUITY UPLC BEH C18 (1.7 µm, 2.1 × 50 mm) column using a mobile phase consisting of formic acid, water, and acetonitrile at a flow rate of 0.60 mL/min. NIF was identified and quantified via mass spectrometry with electrospray ionization (ESI) in positive ion mode and multiple reaction monitoring (MRM). The method showed linearity in the range of 0.25 - 150 ng/mL for NIF. The developed and validated method was applied to the bioequivalence study in human plasma samples.