The relative bioavailability of glipizide in human body / 医学研究生学报

ABSTRACT

Objectives:To study the pharmacokinetics and relative bioavailability of glipizide in healthy male volunteers. Methods:The glipizide concentrations in plasma were determined by HPLC UV. The column Lichrospher C18 (5 ?m,150 mm?4.6 mm),the mobile phase methanl∶0.01 mol/L sodium acetale buffer (pH 4.8) (59 ∶41); the flow rate1 ml/min, the detection wavelength 225 nm. The test and reference formulations of glipizide were given to 20 healthy male volunteers. Results: The calibration curve was linear within the range of (25～1 000)?g/L, r =0.999 4. The minimum detection limit was 25 ?g/L. The mean recovery was 89.84%, CV of inter day and intra day were no more than 5%.After a single oral dose of 10 mg glipizide test or reference tablet, the main pharmacokinetic parameters AUC 0-15, AUC 0-∞, T max ,C max and t 1/2 were (3 502.78?635.82) , (3 214.23?590.46)?g/( L?h),(3 868.22?699.93), (3 593.94?638.60)?g/(L?h),(3.85?1.44), (3.76?1.13)h, (550.80?110.19), (531.15?148.42)?g/L,(3.57?1.11)h and (3.80?1.06)h ,respectively. The relative bioavailability F 0-15 ,F 0-∞ were (110.6?19.8)% and (108.8?17.9)%. Conclusions: No significant difference exists among the pharmacokinetic parameters for the experimental tablets and the reference. The two formulations were bioequivalent.