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Validated UPLC-MS/MS method for quantification of fruquintinib in rat plasma and its application to pharmacokinetic study

Authors Mei YB, Luo SB, Ye LY, Zhang Q, Guo J, Qiu XJ, Xie SL

Received 24 December 2018

Accepted for publication 25 July 2019

Published 15 August 2019 Volume 2019:13 Pages 2865—2871

DOI https://doi.org/10.2147/DDDT.S199362

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 6

Editor who approved publication: Dr Sukesh Voruganti


Yi-Bin Mei,1,* Shun-Bin Luo,2,* Ling-Yan Ye,1 Qiang Zhang,3 Jing Guo,4 Xiang-Jun Qiu,5 Sai-Li Xie6

1Department of Cardiology, The People’s Hospital of Lishui, Lishui, Zhejiang 323000, People’s Republic of China; 2Department of Clinical Pharmacy, The People’s Hospital of Lishui, Lishui, Zhejiang 323000, People’s Republic of China; 3Department of Clinical Laboratory, The People’s Hospital of Lishui, Lishui, Zhejiang 323000, People’s Republic of China; 4Department of Regional Medical Union, The People’s Hospital of Lishui, Lishui, Zhejiang 323000, People’s Republic of China; 5Department of pharmacology, Medical College of Henan University of Science and Technology, Luoyang 471003, People’s Republic of China; 6Department of Ultrasonic imaging, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325035, People’s Republic of China

*These authors contributed equally to this work

Abstract: A new, simple, and sensitive ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for quantification of fruquintinib was established to assess the pharmacokinetics of fruquintinib in the rat. The internal standard working solution was added to the plasma sample for extraction before analysis. The Acquity UPLC BEH C18 chromatography column (2.1 mm ×50 mm, 1.7 μm) was used to separated analytes under gradient elution using acetonitrile and 0.1% formic acid as the mobile phase. Positive multiple reaction monitoring modes were chosen to detect fruquintinib and diazepam (IS). The precursor-to-product ion transitions were 394.2 → 363.2 for fruquintinib and m/z 285 → 154 for IS. The current method was linear over the concentration range of 1.0–1000 ng/mL for fruquintinib with a correlation coefficient of 0.9992 or better. The matrix effect of fruquintinib and IS was acceptable under the current method. The intra- and interday precision (RSD%) and accuracy (RE%) were within 11.9% and ±13.7%, respectively. The recovery, stability, and sensitivity were validated according to the United States Food and Drug Administration (FDA) regulations for bioanalytical method validation. The analytical method had been validated and applied to a pharmacokinetic study of fruquintinib in rat.

Keywords: fruquintinib, UPLC-MS/MS, rat plasma, pharmacokinetics

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