- Author:
Peng LIU
1
Author Information
- Publication Type:Journal Article
- Keywords: Bioequivalence; LC-MS/MS; Pantoprazole
- From: Chinese Pharmaceutical Journal 2013;48(8):633-635
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To determine the concentration of pantoprazole in human plasma and evaluate the bioequivalence of two kinds of pantoprazole sodium enteric-coated tablets. METHODS: The concentration of pantoprazole in human plasma was determined by LC-MS/MS, and the pharmacokinetic parameters for evaluation of bioequivalence were calculated with DAS2.0. RESULTS: The main pharmacokinetic parameters of test and reference formulation were as follows; t1/2 (1.96±0.66) and (1.98±0.59) h, (3.17±0.84) and (3.09±0.81) h, pmax(3.53±0.78) and (3.41±0.79) μg · mL-1, AUC0-∞ (10.12±4.09) and (10.86±3.99) μg · h · mL-1. The relative bioavailability was (97.9±22.3)%. CONCLUSION: The method is repeatable and sensitive. The test and reference formulation are bioequivalent.