Determination of Lansoprazole in Human Plasma by HPLC:Application to Bioequivalence and Pharmacokinetics Study

Aim To study the pharmacokinetics of lansoprazole tablets in human plasma. Methods Nineteen volunteers were given the lansoprazole tablets by oral administration with 2-way crossover design. The concentration of lansoprazole in plasma was determined by HPLC while the pharmacokinetic parameters were calculated by DAS software.Results The calibration curve was linear in the range from 20ng·mL-1 to 2 000ng·mL-1. The relative recovery was more than 95.14%. The intra and inter-day RSD was below 13.2%. The main pharmacokinetic parameters t1/2,Cmax,Tmax and AUC0→t for the test preparations were(2.24±0.89)h,(818.0±275.2)ng·mL-1,(2.45±0.47)h and (2 405±1 141)ng·h·mL-1,respectively. Those for the reference preparations were(2.18±0.85)h,(859.3±311.3)ng·mL-1,(2.45±0.47)h and (2 511±1 351)ng·h·mL-1,respectively. The relative bioavalability of the test preparations was (99.9±15.9)%. Conclusion The HPLC method for determination of lansoprazole in plasma proved to be sensitive accurate and convenient. The reference and test preparations are bioequivalent.