Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application

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...

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Main Authors: Fengting Ou, Ying Zhou, Jinxiu Lei, Su Zeng, Fuhai Wu, Ning Zhang, Lushan Yu
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:Journal of Pharmaceutical Analysis
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2095177919304642
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author Fengting Ou
Ying Zhou
Jinxiu Lei
Su Zeng
Fuhai Wu
Ning Zhang
Lushan Yu
author_facet Fengting Ou
Ying Zhou
Jinxiu Lei
Su Zeng
Fuhai Wu
Ning Zhang
Lushan Yu
author_sort Fengting Ou
collection DOAJ
description 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. 5 μm), 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.
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spelling doaj.art-6b2ee1935e2c406288ecc538763ac9c62022-12-21T18:10:58ZengElsevierJournal of Pharmaceutical Analysis2095-17792020-12-01106617623Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic applicationFengting Ou0Ying Zhou1Jinxiu Lei2Su Zeng3Fuhai Wu4Ning Zhang5Lushan Yu6Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, China; School of Pharmacy, Guangdong Pharmaceutical University, Guangdong, 510006, ChinaInstitute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, ChinaInstitute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, ChinaInstitute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, ChinaSchool of Public Health, Guangdong Pharmaceutical University, Guangdong, 510006, ChinaInstitute of Nuclear Agricultural Sciences, Zhejiang University, Hangzhou, 310058, China; Corresponding author.Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, China; Corresponding author.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. 5 μm), 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.http://www.sciencedirect.com/science/article/pii/S2095177919304642IlaprazoleEnantiomerLC-MS/MSPharmacokinetics
spellingShingle Fengting Ou
Ying Zhou
Jinxiu Lei
Su Zeng
Fuhai Wu
Ning Zhang
Lushan Yu
Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
Journal of Pharmaceutical Analysis
Ilaprazole
Enantiomer
LC-MS/MS
Pharmacokinetics
title Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
title_full Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
title_fullStr Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
title_full_unstemmed Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
title_short Development of a UHPLC-MS/MS method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
title_sort development of a uhplc ms ms method for the quantification of ilaprazole enantiomers in rat plasma and its pharmacokinetic application
topic Ilaprazole
Enantiomer
LC-MS/MS
Pharmacokinetics
url http://www.sciencedirect.com/science/article/pii/S2095177919304642
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