Pharmacokinetics and bioequivalence studiesof cefteram pivoxil in healthy Chinese volunteers

摘要

A simple, sensitive and specific method has been developed for the determination of cefteram in human plasma. Sample preparation was accomplished through protein precipitation with 20% trichloroacetic acid (v/v) and chromatographic separation was performed on a Cia column at 25 °C. The mobile phase consisted of methanol-aqueous 20mM ammonium acetate (18∶82, v/v) at flow rate of l.OmL/min. Wavelength was set at 235nm. The lower limit of quantification was 0.04μg/mL and the assay exhibited a linear range of 0.04–3.2μg/mL (r=0.9996). The relative recoveries of cefteram from human plasma at three different concentrations were more than 90%. The method was successfully applied to investigate the bioequivalence between two kinds of cefteram pivoxil preparations (test vs reference) in 24 healthy Chinese volunteers. After a single 100mg dose for the test and reference product, the resulting means of major pharmacokinetic parameters such asAUC 0?t,AUC 0?∞,C max andT max of cefteram pivoxil were 4.75±1.35 vs 4.76±1.29μg h/mL, 4.89±1.36 vs 4.91±1.29μg h/mL, 1.65±0.45 vs 1.73±0.45μg/mL and 1.48±0.59 vs 1.73±0.45h, respectively, indicating that these two kinds of preparations were bioequivalent.