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.
Author
(s) Details
Hyun-Jin Kim, PhD
Department of Pharmacology, Clinical Pharmacology Laboratory, Division of
Molecular Therapeutics Development, Hanyang Biomedical Research Institute,
College of Medicine, Hanyang University, Seoul, South Korea.
Ju-Seop Kang
Department of Pharmacology, Clinical Pharmacology Laboratory, Division of
Molecular Therapeutics Development, Hanyang Biomedical Research Institute,
College of Medicine, Hanyang University, Seoul, South Korea.
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