TITLE:
Clinical Pharmacokinetic and Bioequivalence Studies of Two Brands of Cephradine in Healthy Korean Using HPLC Method
AUTHORS:
Hyun-Jin Kim, Shin-Hee Kim, Semi Kim, Jae-Sung Ahn, Ju-Seop Kang
KEYWORDS:
Bioequivalence, Cephalosporin Antibiotic, Cephradine, Korean Volunteers, Pharmacokinetics
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.9 No.7,
July
31,
2018
ABSTRACT: 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 as simple sample preparation, a short
retention time (less than 6 min) and making it suitable for use in clinical
trials. Pharmacokinetic parameters, such as AUC0-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
interval 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 in normal subjects.