Liquid chromatographic determination of ceftibuten, a new oral cephalosporin, in human plasma and urine.

Two liquid chromatographic methods with UV detection were developed for the determination of ceftibuten in human plasma and urine. Diluted plasma samples were directly injected onto a reversed-phase column without prior protein precipitation while diluted urine samples were processed through an automated on-line sample clean-up procedure using column-switching. Both methods were linear over clinically relevant concentration ranges in plasma (from 0.1 to 50 micrograms ml-1) and urine (from 0.5 to 60 micrograms ml-1). The methods showed acceptable precision (RSD < 20%) and accuracy (bias < 15%) at the limit of quantitation (LOQ) for ceftibuten in plasma and urine. These LOQs represented the lowest concentrations of ceftibuten in plasma (0.1 micrograms ml-1) and urine (0.5 micrograms ml-1) that could be measured with acceptable precision and accuracy. RSDs for both within-day and between-day analyses were < or = 12% for plasma and < 7% for urine. These methods have been used successfully for the analysis of ceftibuten in plasma and urine following single oral doses of 200, 400 and 800 mg in man.