Pharmacokinetics of domestic and imported nevirapine tablets in healthy volunteers

OBJECTIVE To develop an HPLC method for the determining the concentration of nevirapine in plasma and investigate the pharmacokinetics in healthy volunteers.RESULTS A single oral dose 200 mg of nevirapine tablets was given to 10 healthy volunteers,and the concentrations of nevirapine in plasma were determined by established HPLC method.METHODS The linear correlation of nevirapine was observed for the concentration of(62.5)-(4 000) μg·L~(-1)(r=(0.999 9)).Precision and stability of the method were fine.The results revealed that the data of nevirapine were fitted to a one-compartment open model.The main pharmacokinetic parameters of nevirapine were as follows: C_(max) was((2 357)±387)μg·L~(-1);t_(max)was((3.7)±(1.0))h;t_(1/2ka) was((0.7)±(0.9)) h;t_(1/2ke) was((54.1)±(15.4)) h;CL/F was((1.2)±(0.3)) L·h~(-1);V/F was((93.4)±(18.1)) L;AUC_(0-t) was((154.5)±(34.5)) mg·h·L~(-1);AUC_(0-∞)was((173.7)±(44.1)) mg·h·L~(-1).CONCLUSION The method is convenient,sensitive and accurate for determining the plasma nevirapine concentration and studying pharmacokinetics.