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Simultaneous determination of nintedanib and its metabolite by UPLC-MS/MS in rat plasma and its application to a pharmacokinetic study.
J Pharm Biomed Anal. 2016 Jan 05; 117:173-7.JP

Abstract

To establish a rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of concentration of nintedanib and its metabolite BIBF 1202 in rat plasma. The nintedanib and its metabolite and the internal standard (diazepam) were separated on an Acquity UPLC BEH C18 chromatography column (2.1 mm×50 mm, 1.7 μm) using gradient elution with a mobile phase of acetonitrile and 0.1% formic acid in water at a flow rate of 0.30 mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode to monitor the precursor-to-product ion transitions of m/z540.3→113.1 for nintedanib, m/z526.3→113.0 for BIBF 1202 and m/z285.3→193.1 for diazepam (IS) using a positive electrospray ionization interface. The method was validated for 1.0-200 ng/mL for nintedanib and 0.5-100 ng/mL for BIBF 1202 using 100 μL of plasma sample. Total time for each chromatograph was 3.0 min. The intra- and inter-day precision and accuracy of the quality control samples at low, medium, and high concentration levels exhibited relative standard deviations (RSD) <10.8% and the accuracy values ranged from -11.9% to 10.4%. The method was successfully applied to a pharmacokinetic study of nintedanib and BIBF 1202 in rats after oral administration of nintedanib.

Authors+Show Affiliations

Department of Forensic Medicine, School of Medicine, Xi'an Jiaotong University, Xi'an 710061, PR China; School of Pharmacy of Wenzhou Medical University, Wenzhou 325035, PR China.The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, PR China.Medical College of Henan University of Science and Technology, Luoyang 471003, PR China.Medical College of Henan University of Science and Technology, Luoyang 471003, PR China.Department of Forensic Medicine, School of Medicine, Xi'an Jiaotong University, Xi'an 710061, PR China. Electronic address: lxins@mail.xjtu.edu.cn.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26355771

Citation

Lin, Dan, et al. "Simultaneous Determination of Nintedanib and Its Metabolite By UPLC-MS/MS in Rat Plasma and Its Application to a Pharmacokinetic Study." Journal of Pharmaceutical and Biomedical Analysis, vol. 117, 2016, pp. 173-7.
Lin D, Qiao LM, Zhang YN, et al. Simultaneous determination of nintedanib and its metabolite by UPLC-MS/MS in rat plasma and its application to a pharmacokinetic study. J Pharm Biomed Anal. 2016;117:173-7.
Lin, D., Qiao, L. M., Zhang, Y. N., Liu, Y., & Liu, X. S. (2016). Simultaneous determination of nintedanib and its metabolite by UPLC-MS/MS in rat plasma and its application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 117, 173-7. https://doi.org/10.1016/j.jpba.2015.08.024
Lin D, et al. Simultaneous Determination of Nintedanib and Its Metabolite By UPLC-MS/MS in Rat Plasma and Its Application to a Pharmacokinetic Study. J Pharm Biomed Anal. 2016 Jan 5;117:173-7. PubMed PMID: 26355771.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of nintedanib and its metabolite by UPLC-MS/MS in rat plasma and its application to a pharmacokinetic study. AU - Lin,Dan, AU - Qiao,Li-man, AU - Zhang,Yu-niao, AU - Liu,Yuan, AU - Liu,Xin-she, Y1 - 2015/08/28/ PY - 2015/05/08/received PY - 2015/08/14/revised PY - 2015/08/19/accepted PY - 2015/9/11/entrez PY - 2015/9/12/pubmed PY - 2016/8/27/medline KW - BIBF 1202 KW - Nintedanib KW - Pharmacokinetics KW - Plasma KW - UPLC–MS/MS SP - 173 EP - 7 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 117 N2 - To establish a rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of concentration of nintedanib and its metabolite BIBF 1202 in rat plasma. The nintedanib and its metabolite and the internal standard (diazepam) were separated on an Acquity UPLC BEH C18 chromatography column (2.1 mm×50 mm, 1.7 μm) using gradient elution with a mobile phase of acetonitrile and 0.1% formic acid in water at a flow rate of 0.30 mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode to monitor the precursor-to-product ion transitions of m/z540.3→113.1 for nintedanib, m/z526.3→113.0 for BIBF 1202 and m/z285.3→193.1 for diazepam (IS) using a positive electrospray ionization interface. The method was validated for 1.0-200 ng/mL for nintedanib and 0.5-100 ng/mL for BIBF 1202 using 100 μL of plasma sample. Total time for each chromatograph was 3.0 min. The intra- and inter-day precision and accuracy of the quality control samples at low, medium, and high concentration levels exhibited relative standard deviations (RSD) <10.8% and the accuracy values ranged from -11.9% to 10.4%. The method was successfully applied to a pharmacokinetic study of nintedanib and BIBF 1202 in rats after oral administration of nintedanib. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/26355771/Simultaneous_determination_of_nintedanib_and_its_metabolite_by_UPLC_MS/MS_in_rat_plasma_and_its_application_to_a_pharmacokinetic_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(15)30122-9 DB - PRIME DP - Unbound Medicine ER -