A Pharmacokinetic Study of Omeprazole in Plasma by Liquid Chromatography Spectrometry

Objective A sensitive and specific high performance liquid chromatography(HPLC) assay was developed to study the relative bioequivalence and bioavailability of omeprazole in plasma. Methods Twenty volunteers were orally given with omeprazole capsules and enteric capsules as a standard,respectively,in a randomized crossover test.The concentration of omeprazole in plasma was determined by RP-HPLC and pharmacokinetic parameters were calculated by DAS2.0 Software. Results The pharmacokinetic parameters of the test and reference formulations were as follows: Cmax were(1 176.26±622.48) and(1 278.19±733.30) ng·mL-1,AUC0→t were(3 514.80±3 353.86)and(3 800.49±3 566.14) ng·mL-1·h,AUC0→∞ were(3 696.12±3 667.41) and(4 017.86±3 925.34) ng·mL-1·h,tmax were(2.65±0.93)and(2.45±0.94) h.No significant difference for parameters of the two formulations was found. Conclusion The two formulations are bioequivalent.