Study On Effects Of Food-intake On Pharmacokinetics And Bioequivalence Of Telmisartan Tablet In Normal Subjects

Objective To establish a high performance liquid chromatography–fluocescence detection(HPLC-FD) method in order to determine the concentration of telmisartan in human plasma, We used the method and investigated whether there was the influence on telmisartan's pharmacokinetic parameters under the conditions of fasting and after fatty meal, and between domestic and Germany telmisartan tablets after a single oral dose of 80 mg.Methods (1) Separation was achieved on the Waters symmetry C18 column, The mobile phase consisted of acetonitrile-0.1 mol/L sodium acetate (42:58) and the flow rate was 1.0 mL/min, the fluorimetric excitation and emission wavelengths were set at 300 nm and 380 nm, respectively. (2) A single oral dose of telmisartan 80 mg was given to 10 healthy volunteers by random cross experiment under the conditions of fasting and after meal. The plasma concentration of telmisartan was determined by HPLC-FD, the compartment model of fit was performed by 3P97 procedure and the pharmacokinetic parameters were calculated by excel procedure. (3) In the study of bioequivalence, a single oral dose of domestic and Germany telmisartan tablets was given to 18 healthy volunteers. The plasma concentration of telmisartan at different time before and after oral administration was determined by HPLC-FD, the compartment model of fit and pharmacokinetic parameters were performed by 3P97 procedure to analyse wether domestic and Germany telmisartan were bioequivalent.Results (1) The retention time of telmisartan was about 8.8 min. The calibration curves were linear in the range of 2.0~1000.0 ng/mL.The recovery, precision and nicetyof...