Pharmacokinetics and Bioequivalence Study of Lansoprazole Tablets in Chinese Healthy Volunteers

OBJECTIVE To establish an HPLC method for the determination of lansoprazole in human plasma to evaluate the bioequivalence of lansoprazole tablets and orally disintegrating tablets. METHODS Twenty volunteers were randomly divided into two groups(test and reference)，with double cross over design, single oral dose of lansoprazole at the dose of 30 mg of test tablets and reference orally disintegrating tablets were delivered, respectively. After adding omeprazole, the internal standard, and 200 μL of 0.1 mol·L-1 Na2CO3 solution, the plasma samples were extracted with diethyl ether-dichloromethane and separated on an ODS C18 column(150 mm × 4.6 mm, 5 μm). The mobile phase was methanol-acetonitrile-water (15∶28∶57) and detected at 285 nm. RESULTS The pharmacokinetic parameters of test tablets and reference orally disintegrating tablets were as follows: Tmax were (1.8 ± 0.5) and (1.9 ± 0.5) h; Cmax were (1 144 ± 240.8) and (1 162 ± 267.4) ng·mL-1; t1/2 were (1.4 ± 0.3) and (1.4 ± 0.3) h; AUC0～12 were (3 258 ± 1 222) and (3 055 ± 1 151) ng·h·mL-1; AUC0-∞ were (3 341 ± 1251) and (3 135 ± 1 182) ng·h·mL-1, respectively．The relative bioavalibility of lansoprazole tablets was (108.7 ± 21.6)% (n=20). CONCLUSION The statistical analysis showed that the test and reference preparation were bioequivalent.