Study On Pharmacokinetics And Bioanailabilty Of Amlodipine

OBJECTIVE: To study the pharmacokinetics and the relativebioavailability ofAmlodipine tablet in healthy male volunteers.METHOD: An analytical method for the determination ofpharmacokinetics and bioavailability of amlodipine in human plasmahas been developed based on liquid chromatography–tandem massspectrometry. Two tablet formulations of amlodipine have beenadministered to 24 healthy male volunteers, respectively.Pharmacokinetic parameters were determined by standardnoncompartmental methods.RESULTS: Pharmacokinetic parameters were Cmax 2.19± 0.75 and2.23 ±0.71 ng/mL, Tmax 5.9±1.8 and 7.3±6.3 h, t1/2 36.91 ± 10.02 and39.57±15.40 h, AUC0-t 83.90 ± 26.12 and 82.31 ± 26.24 ng?h/mL, andAUC0-∞ 102.94± 35.67 and 103.29 ± 39.05 ng?h/mL for Test and Referenceformulations, respectively. The 90% confidence interval of Cmax(81.78-115.88%), AUC0 t (91.30-120.16%) and AUC0 ∞ (96.34-120.50%)were found within FDA acceptance range of 80-125%.CONCLUSION: It is concluded that the test formulation isbioequivalent to the reference formulation.