Automated assay for GV104326, a novel tribactam antibiotic, in human plasma by high-performance liquid chromatography and solid-phase extraction

A highly automated, rapid, robust and specific plasma assay for GV104326, a novel tribactam antibiotic, has been developed to monitor human volunteer trials. The method involves automated solid-phase extraction with a strong anion-exchange phase and HPLC on a reversed-phase column with ultraviolet detection. The calibration range for the assay is 0.05–2 μg/ml. The assay is linear over this range and is specific with respect to endogenous interference and likely metabolites of GV104326. Both intra- and inter-assay variability were < 8% and intra- and inter-day bias < 10%.