Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
- Author:
Fengting OU
1
,
2
;
Ying ZHOU
;
Jinxiu LEI
;
Su ZENG
;
Fuhai WU
;
Ning ZHANG
;
Lushan YU
Author Information
1. Institute of Drug Metabolism and Pharmaceutical Analysis,College of Pharmaceutical Sciences,Zhejiang University,Hangzhou,310058,China
2. School of Pharmacy,Guangdong Pharmaceutical University,Guangdong,510006,China
- Keywords:
Ilaprazole;
Enantiomer;
LC-MS/MS;
Pharmacokinetics
- From:
Journal of Pharmaceutical Analysis
2020;10(6):617-623
- CountryChina
- Language:Chinese
-
Abstract:
In Korea and China, ilaprazole is a widely used proton pump inhibitor in the treatment of gastric ulcers. In this study, a specific and sensitive LC-MS/MS method has been developed and validated for the quantification of ilaprazole enantiomers in the rat plasma, using R-lansoprazole as the internal standard. The enantioseparation was achieved on a CHIRALPAK AS-RH column (4.6 mm × 150 mm, i.d. 5μm), with a mobile phase composed of 10 mM ammonium acetate aqueous solution and acetonitrile (60:40, V/V), at a flow-rate of 0.5 mL/min. The method was validated over the concentration range of 0.5-300 ng/mL for both, R- and S -ilaprazole. The lower limit of quantification was 0.5 ng/mL for both enantiomers. The relative standard deviation (RSD) of intra- and inter-day precision of R-ilaprazole and S-ilaprazole was less than 10.9％, and the relative error accuracy (RE) ranged from -0.5％-2.0％. Finally, the method was successfully evaluated in rats in a stereoselective pharmacokinetic study of the ilaprazole racemate.
