A Novel UPLC-MS/MS Method for Determining Tegoprazan in Rat Plasma: An Application in a Rat Pharmacokinetic Study
Abstract
Tegoprazan (TEG) is a commonly used drug in the treatment of gastroesophageal reflux disease. This work aimed to develop and validate an ultra-high-performance liquid chromatography-tandem mass Spectrometry (UPLC-MS/MS) method to determine the levels of TEG in rat plasma and to apply it for a rat pharmacokinetic study. Electrospray ionization source (ESI) positive and multiple reaction monitoring (MRM) mode were selected. The internal standard revaprazan (REV) and TEG were analyzed separately on a Waters ACQUITY UPLC BEH column. Gradient elution with a flow rate of 0.5 mL/min was used. Accuracy and precision were from -8.5% to 12.2%. Linearity was from 2 to 1000 ng/mL. IS-normalized recovery ranged from 109.3% to 113.6%. IS-normalized matrix effect was from 99.0% to 102.8%. The coefficient of variation of matrix effect was less than 10%. Dilution integrity showed that a tenfold dilution also met the guidelines. In the rat pharmacokinetic study, AUC(0 - ∞) and Cmax of TEG were 9129.6 ± 1823.3 μg/L*h and 2513.2 ± 707.0 ng/mL, respectively. Tmax and T1/2 were 1.8 ± 1.1 h and 1.6 ± 0.8 h, respectively. We finally established a rapid and robust UPLC-MS/MS quantitative analysis of TEG in rat plasma. Rat pharmacokinetics indicated that TEG was absorbed quickly and fast reached the maximum concentration.
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