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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2020-01-01
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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 1687-8779 |
language | English |
publishDate | 2020-01-01 |
publisher | Wiley |
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series | International Journal of Analytical Chemistry |
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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