Pharmacokinetics and bioequivalence studies of cefteram pivoxil in healthy Chinese volunteers.
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 C18 column at 25 degrees C. The mobile phase consisted of methanol-aqueous 20 mM ammonium acetate (18:82, v/v) at flow rate of 1.0 mL/min. Wavelength was set at 235 nm. The lower limit of quantification was 0.04 microg/mL and the assay exhibited a linear range of 0.04-3.2 microg/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 100 mg dose for the test and reference product, the resulting means of major pharmacokinetic parameters such as AUC(0-t), AUC(0-infinity), Cmax and Tmax of cefteram pivoxil were 4.75 +/- 1.35 vs 4.76 +/- 1.29 microg h/mL, 4.89 +/- 1.36 vs 4.91 +/- 1.29 microg h/mL, 1.65 +/- 0.45 vs 1.73 +/- 0.45 microg/mL and 1.48 +/- 0.59 vs 1.73 +/- 0.45 h, respectively, indicating that these two kinds of preparations were bioequivalent.
Wei
Fangmi
F
School of Pharmacy, Nanjing Medical University, Nanjing, Jiangsu, People's Republic of China.
Zhu
Rong
R
Zhao
Wenhui
W
Yang
Jing
J
Cai
Zheng
Z
Hu
Qin
Q
D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D044466:Asian People; D002214:Capsules; D015281:Cefmenoxime / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D002681:China; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D013810:Therapeutic Equivalency; D055815:Young Adult
D000900:Anti-Bacterial Agents; D002214:Capsules; C046817:cefteram pivoxil; D015281:Cefmenoxime