Comparative Assessment of Clinical Pharmacokinetic and Bioequivalence Studies of Two Brands of Cephradine in Healthy Korean Volunteers Using HPLC Method

The goal of our research was to compare the pharmacokinetics and evaluate the bioequivalence of
two brands of cephradine 500 mg capsules in 24 normal Korean volunteers. The plasma samples
were acquired at 13 time points for 8 h after administration. The concentrations of cephradine in
human plasma were measured by a high-performance liquid chromatography (HPLC). Isocratic
mobile phase which consisted of acetonitrile, methanol, and 20 mM potassium phosphate (15/5/80,
v/v/v, pH 3.48) was used to separate the analytical column cosmosil cholester (250 × 4.6 mm, 3 μm).
Analytes were detected in ultraviolet (260 nm). The novel analytical method was described assimple
sample preparation, a short retention time (less than 6 min) and makingit suitable for use in clinical
trials. Pharmacokinetic parameters, such asAUC0-t (20.54 vs 18.42 μg∙h/mL), AUC0-infinity (21.22 vs
19.14 μg∙h/mL), Cmax(12.69 vs 12.81 μg/mL), Tmax (1.22 vs 0.92 h), half-life (1.02 vs 1.13 h),
extrapolation(3.22% vs 3.75%), and Ke (0.73 vs 0.69 h−1) were determined for the reference and test
drugs in plasma. Pharmacokinetic parameters with a 90% confidence intervals were 87~95% for
AUC0-t and 91~115% for Cmax. They were satisfied within the bioequivalence range 80~125% of the
KFDA guidelines. Therefore, our HPLC method was well applied in a bioequivalence and
pharmacokinetic study of two formulations of cephadrine capsules (500 mg) in normal subjects.