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KMID : 0369820050350020117
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 2 p.117 ~ p.122
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Bioavailability of Cefaclor Capsules Using an Improved Analytical Method of Cefaclor in Human Plasma
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김태완/Kim TW
송옥경/한선영/박미진/강성화/신관석/Song OK/Han SY/Park MJ/Kang SH/Sin KS
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Abstract
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After establishing improved HPLC analytical method ofcefaclor in human plasma samples, a bioavailability study of cefaclor capsules was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). The standard calibration curve using an HPLC with UV detector was constructed in a range of 0.0324--16 μg/m1. The 6% perchloric acid instead of 6% trichloroacetic acid was used to precipitate plasma protein. The HPLC chromatograms were precisely and accurately resolved when spiked with human plasma spiked with cefaclor and cephalexin (internal standard). Twenty healthy male Korean volunteers received two commercial cefaclor capsules, Neocef ` capsule (Jinyang Pharm. Co., Ltd) or Ceclor" capsule {Lilly Korea. Co., Ltd.) at the 250 mg cefaclor in a 2 x 2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of cefaclor were monitored for 8 hours after oral drug administration. AUC, the area under the plasma concentration-time curve from time zero to 8 hr (13 points), was calculated by the linear trapezoidal rule method. C,,,a" (maximum plasma drug concentration) and Tmax (time to reach Cma,) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC, and Cmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the AUC, ratio and the Cmax ratio for Neocer/Ceclor" were 0.9049 S S < 1.0304 and 0.9776 5 S 1.226, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of Neocef"/Ceclor" with respect to the extent of absorption.
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KEYWORD
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Cefaclor capsules, Dissolution, HPLC, Pharmacokinetic prarameters, Bioequivalence
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