Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application

In our research, a straightforward UPLC-MS/MS method, with diazepam as the internal standard (IS), was proposed and acknowledged to determine the concentrations of enasidenib in rat plasma. When preparing the sample, we used acetonitrile for protein precipitation. The gradient elution method was use...

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Main Authors: Shuang-long Li, Yong-liang Zhu, Yi Zhang, Shu-han Liu, Xiang-die Wang, Xiang-jun Qiu
Format: Article
Language:English
Published: Wiley 2020-01-01
Series:International Journal of Analytical Chemistry
Online Access:http://dx.doi.org/10.1155/2020/5084127
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author Shuang-long Li
Yong-liang Zhu
Yi Zhang
Shu-han Liu
Xiang-die Wang
Xiang-jun Qiu
author_facet Shuang-long Li
Yong-liang Zhu
Yi Zhang
Shu-han Liu
Xiang-die Wang
Xiang-jun Qiu
author_sort Shuang-long Li
collection DOAJ
description In our research, a straightforward UPLC-MS/MS method, with diazepam as the internal standard (IS), was proposed and acknowledged to determine the concentrations of enasidenib in rat plasma. When preparing the sample, we used acetonitrile for protein precipitation. The gradient elution method was used, and the mobile phase was acetonitrile and 0.1% formic acid. Diazepam was used as the IS. We used the Acquity UPLC BEH C18 column to separate enasidenib and IS. Under the positive ion electrospray ionization (ESI) source conditions, the mass transfer pairs of enasidenib were monitored by multiple reaction monitoring (MRM) to be m/z 474.2 ⟶ 456.1 and m/z 474.2 ⟶ 267.0, and the IS mass transfer pairs were m/z 285.0 ⟶ 154.0. Enasidenib had good linearity (r2 = 0.9985) in the concentration range of 1.0–1000 ng/mL. Besides, the values of intraday and interday precision were 2.25–8.40% and 3.94–5.46%, respectively, and the range of the accuracy values varied from −1.44 to 2.34%. Matrix effect, extraction recovery, and stability were compliant with FDA approval guidelines in terms of bioanalytical method validation. We had established a new method that had been applied to the pharmacokinetic study of enasidenib in rats.
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institution Kabale University
issn 1687-8760
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spelling doaj-art-9ab7fc4fb89f460691a7756d50e8fd9a2025-02-03T05:44:15ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792020-01-01202010.1155/2020/50841275084127Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic ApplicationShuang-long Li0Yong-liang Zhu1Yi Zhang2Shu-han Liu3Xiang-die Wang4Xiang-jun Qiu5Medical College of Henan University of Science and Technology, Luoyang 471023, ChinaMedical College of Henan University of Science and Technology, Luoyang 471023, ChinaMedical College of Henan University of Science and Technology, Luoyang 471023, ChinaMedical College of Henan University of Science and Technology, Luoyang 471023, ChinaMedical College of Henan University of Science and Technology, Luoyang 471023, ChinaMedical College of Henan University of Science and Technology, Luoyang 471023, ChinaIn our research, a straightforward UPLC-MS/MS method, with diazepam as the internal standard (IS), was proposed and acknowledged to determine the concentrations of enasidenib in rat plasma. When preparing the sample, we used acetonitrile for protein precipitation. The gradient elution method was used, and the mobile phase was acetonitrile and 0.1% formic acid. Diazepam was used as the IS. We used the Acquity UPLC BEH C18 column to separate enasidenib and IS. Under the positive ion electrospray ionization (ESI) source conditions, the mass transfer pairs of enasidenib were monitored by multiple reaction monitoring (MRM) to be m/z 474.2 ⟶ 456.1 and m/z 474.2 ⟶ 267.0, and the IS mass transfer pairs were m/z 285.0 ⟶ 154.0. Enasidenib had good linearity (r2 = 0.9985) in the concentration range of 1.0–1000 ng/mL. Besides, the values of intraday and interday precision were 2.25–8.40% and 3.94–5.46%, respectively, and the range of the accuracy values varied from −1.44 to 2.34%. Matrix effect, extraction recovery, and stability were compliant with FDA approval guidelines in terms of bioanalytical method validation. We had established a new method that had been applied to the pharmacokinetic study of enasidenib in rats.http://dx.doi.org/10.1155/2020/5084127
spellingShingle Shuang-long Li
Yong-liang Zhu
Yi Zhang
Shu-han Liu
Xiang-die Wang
Xiang-jun Qiu
Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application
International Journal of Analytical Chemistry
title Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application
title_full Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application
title_fullStr Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application
title_full_unstemmed Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application
title_short Development and Validation of UPLC-MS/MS Method for Determination of Enasidenib in Rat Plasma and Its Pharmacokinetic Application
title_sort development and validation of uplc ms ms method for determination of enasidenib in rat plasma and its pharmacokinetic application
url http://dx.doi.org/10.1155/2020/5084127
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AT shuhanliu developmentandvalidationofuplcmsmsmethodfordeterminationofenasidenibinratplasmaanditspharmacokineticapplication
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