Volume 10 Issue 6
Dec.  2020
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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[J]. Journal of Pharmaceutical Analysis, 2020, 10(6): 617-623. doi: 10.1016/j.jpha.2019.09.002
Citation: 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[J]. Journal of Pharmaceutical Analysis, 2020, 10(6): 617-623. doi: 10.1016/j.jpha.2019.09.002

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

doi: 10.1016/j.jpha.2019.09.002
Funds:

D Program of China (No. 2017YFE0102200), and the Fundamental Research Funds for the Central Universities (2017XZZX011-04).

This work was supported by grants from the National Key Research and Development Program of China (2017YFC0908600), the National Natural Science Foundation of China (81773817), the National Key R&

  • Received Date: Jun. 17, 2019
  • Accepted Date: Sep. 17, 2019
  • Rev Recd Date: Sep. 12, 2019
  • Available Online: Jan. 24, 2022
  • Publish Date: Dec. 10, 2020
  • 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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