2008•Chinese Journal of PharmaceuticalsRequires access

Determination of Terbinafine in Human Plasma by HPLC and Its Pharmacokinetics

Gong Zhi-cheng

Abstract

A HPLC method was established for the determination of terbinafine in human plasma.According to a randomized crossover design,the pharmacokinetics after single dose oral administration of test and reference tablets in 18 healthy male volunteers was studied.Terbinafine was linear in the concentration range of 0.05 -2.4μg/ml.The main pharmacokinetic parameters of test and reference tablets were tmax(2.4±0.5) and(2.4±0.6)h,cmax(0.952±0.165) and(0.958±0.171)μg/ml,AUC0→72h(9.960±2.464) and(10.554±3.264)μg·h·ml-1,t1/2(19.9±6.6) and(20.6±5.7)h,respectiveiy.The relative bioavailability of the tested preparation was(96.4±13.6)%.

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Key concepts: Pharmacokinetics, Chemistry, Terbinafine, Cmax, Bioavailability, High-performance liquid chromatography, Bioequivalence, Chromatography