Determination of Bezafibrate Tablets in Human Plasma by HPLC Application to Bioequivalent and Pharmacokinetic Studies

Aim To study the pharmacokinetics of bezafibrate tablets in human plasma.Methods Twenty volunteers were given bezafibrate tablets by oral administration with 2-way crossover design.The concentration of bezafibrate in plasma was determined by HPLC.The pharmacokinetic parameters were calculated by DAS software.Results The calibration curve was linear in the range from 0.1μg·mL-1 to 20.0μg·mL-1.The relative recovery exceeded 92.47%.The intra and inter-day RSD was less than 11.1%.The main pharmacokinetic parameters t1/2,Cmax,Tmax and AUC0→t for the test capsules were(1.63±0.28)h,(11.107±3.184)μg·mL-1,(1.85±0.49)h and(38.9±9.6)μg·h·mL-1,respectively.while those for the reference preparations were(1.57±0.42)h,(11.439±3.388)μg·mL-1,(1.65±0.46)h and(37.4±10.4)μg·h·mL-1,respectively.The relative bioavalability of the test preparations was(105.7±12.8)%.Conclusion The HPLC method for determination of bezafibrate in plasma was proved to be sensitive,accurate and convenient.The reference and test preparations are bioequivalent.