Study on bioequivalence of two nimodipine tablets by HPLC-MS

OBJECTIVE To evaluate the bioequivalence of two domestic nimodipine tablets. METHODS A single oral administration of 60 mg nimodipine tablets was given to 20 health y volunteers. Nimodipine concentrations in plasma were determined by HPLC-MS.RESULTS The main pharmacokinetic parameters of two nimodipine tablets were as follow: t 1/2( 2.1± 0.3),( 2.2± 0.4)h, t max ( 1.5 ± 0.4), ( 1.6± 0.4)h, C max ( 28.2± 7.1), ( 28.8± 7.6) μg·L -1, AUC ( 105.9± 29.5), ( 106.5± 26.4) μg·L -1·h respectively.The relative bioavailability of the test tablet was ( 99.4± 5.3)%.CONCLUSION The results has demonstrated that the two tablets are bioequivalent.