Title: Determination of amlodipine in human plasma by LC-MS and study on its bioequivalence
Abstract: Objective To establish a liquid chromatography-mass spectrometry(LC-MS)method for determining the concentration of amlodipine in human plasma and to evaluate the bioequivalence of two kinds of amlodipine besylate tablets.Methods Eighteen male healthy volunteers received 5 mg amoldipine tablets orally in a random crossover design.Drug concentrations in plasma were determined by LC-MS.Results The main pharmacokinetic parameters of tested tablet and reference tablet were as follows:AUC0→t(104.01±26.03)vs(101.91±24.67)ng·h·ml-1;AUC0→∞(113.96±30.66)vs(110.29±27.67)ng·h·ml-1;Cmax(2.44±0.40)vs(2.43±0.38)ng·ml-1;tmax(7.28±2.92)vs(7.50±3.04)h;t1/2(33.33±6.30)vs(30.93±4.18)h,respectively.The relative bioavailability of the test tablet was(103.34±6.69)%.Conclusions The method is simple to use,fast and accurate.The results demonstrate that the tested tablet and reference tablet are bioequivalent.
Publication Year: 2008
Publication Date: 2008-01-01
Language: en
Type: article
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