Assessment of remdesivir and its nucleoside metabolite in beagle dogs and healthy humans by liquid chromatography coupled with triple quadrupole mass spectrometry.

The aim of this study was to assess the pharmacokinetics of the existing remdesivir intravenous formulation (100 mg dose) against the newly developed oral formulation (20 mg dose) for remdesivir and its active nucleoside metabolite (GS-441524) in beagle dogs followed by healthy human volunteers. A quantification method for remdesivir and its active nucleoside metabolite (GS-441524) in beagle dog and human plasma has been developed and validated using liquid chromatography coupled to triple quadrupole mass spectrometry detection. The analytical methods for beagle dogs and human differ in the calibration curve range, plasma matrix, processing volume, reconstitution volume and injection volume; however all other parameters were same in both methods.

Sensitive and rapid quantitation of dexamethasone in human plasma using liquid chromatography coupled with triple quadrupole mass spectrometer.

The aim of this paper was to develop, validate, and utilize a sensitive liquid chromatography-tandem mass spectrometry bioanalytical method for bioequivalence/clinical trial studies conducted in human plasma. To accomplish the target, a stable labeled internal standard, that is, dexamethasone D was used as an internal standard to track and compensate the parent compound during processing, and extraction from plasma. The method involves a rapid liquid-liquid phase extraction from plasma, followed by reverse phase chromatography, and mass spectrometry detection, with a total run time of 3.

Highly sensitive method for the determination of JI-101, a multi-kinase inhibitor in human plasma and urine by LC-MS/MS-ESI: method validation and application to a clinical pharmacokinetic study.

A highly sensitive, rapid assay method has been developed and validated for the estimation of JI-101 in human plasma and urine using LC-MS/MS-ESI in the positive-ion mode. The assay procedure involves extraction of JI-101 and alfuzosin (internal standard, IS) from human plasma/urine with a solid-phase extraction process. Chromatographic resolution was achieved on two Zorbax SB-C(18) columns connected in series with a PEEK coupler using an isocratic mobile phase comprising acetonitrile-0.