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Quantitative bioanalytical assay for the human epidermal growth factor receptor (HER) inhibitor dacomitinib in rat plasma by UPLC-MS/MS.
J Pharm Biomed Anal 2019; 166:66-70JP

Abstract

Dacomitinib is a highly selective irreversible small-molecule inhibitor of the human epidermal growth factor receptor (HER) family of tyrosine kinases. A simple and quick bioanalytical method was completely developed and validated for the assay and pharmacokinetic investigation of dacomitinib in rat plasma using ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). Proteins in 0.1 mL plasma samples were prepared by precipitant acetonitrile containing ibrutinib as the internal standard (IS). Separation of the analyte from plasma samples was carried out on an Acquity UPLC BEH C18 column using acetonitrile and 0.1% formic acid in water as mobile phase for gradient elution. The total run time and the elution time of dacomitinib were 3.0 min and 1.07 min, respectively. Positive-ion electrospray ionization (ESI) and multiple reaction monitoring (MRM) on a triple quadrupole tandem mass spectrometer were used for detection at the transitions of m/z 470.1 → 124.1 for dacomitinib and m/z 441.2 → 84.3 for ibrutinib (IS), respectively. In the range of 1-150 ng/mL, the calibration curve of dacomitinib was linear with a lower limit of quantitation (LLOQ) of 1 ng/mL. Mean recovery of dacomitinib in plasma was in the range of 76.9-84.1%. The inter- and intra-day precision (RSD) was in the scope of 1.7-8.7% and the accuracy (RE) ranged from -6.1 to 8.5%. Stability studies under different conditions were indicated to be stable. A pharmacokinetic study after oral administration of 40 mg/kg dacomitinib in rats illustrated the applicability of the new presented determination of dacomitinib.

Authors+Show Affiliations

Medical College of Henan University of Science and Technology, 471003 Luoyang, PR China.The First Affiliated Hospital of Wenzhou Medical University, 325000 Wenzhou, PR China; School of Pharmaceutical Sciences, Wenzhou Medical University, 325000 Wenzhou, PR China.Medical College of Henan University of Science and Technology, 471003 Luoyang, PR China.Medical College of Henan University of Science and Technology, 471003 Luoyang, PR China.Medical College of Henan University of Science and Technology, 471003 Luoyang, PR China.The First Affiliated Hospital of Wenzhou Medical University, 325000 Wenzhou, PR China. Electronic address: yelei2020@163.com.The First Affiliated Hospital of Wenzhou Medical University, 325000 Wenzhou, PR China. Electronic address: xiesaili1988@163.com.

Pub Type(s)

Journal Article
Validation Studies

Language

eng

PubMed ID

30612075

Citation

Qiu, Xiangjun, et al. "Quantitative Bioanalytical Assay for the Human Epidermal Growth Factor Receptor (HER) Inhibitor Dacomitinib in Rat Plasma By UPLC-MS/MS." Journal of Pharmaceutical and Biomedical Analysis, vol. 166, 2019, pp. 66-70.
Qiu X, Lin Q, Ning Z, et al. Quantitative bioanalytical assay for the human epidermal growth factor receptor (HER) inhibitor dacomitinib in rat plasma by UPLC-MS/MS. J Pharm Biomed Anal. 2019;166:66-70.
Qiu, X., Lin, Q., Ning, Z., Qian, X., Li, P., Ye, L., & Xie, S. (2019). Quantitative bioanalytical assay for the human epidermal growth factor receptor (HER) inhibitor dacomitinib in rat plasma by UPLC-MS/MS. Journal of Pharmaceutical and Biomedical Analysis, 166, pp. 66-70. doi:10.1016/j.jpba.2018.12.041.
Qiu X, et al. Quantitative Bioanalytical Assay for the Human Epidermal Growth Factor Receptor (HER) Inhibitor Dacomitinib in Rat Plasma By UPLC-MS/MS. J Pharm Biomed Anal. 2019 Mar 20;166:66-70. PubMed PMID: 30612075.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quantitative bioanalytical assay for the human epidermal growth factor receptor (HER) inhibitor dacomitinib in rat plasma by UPLC-MS/MS. AU - Qiu,Xiangjun, AU - Lin,Qianmeng, AU - Ning,Zongdi, AU - Qian,Xin, AU - Li,Pengbo, AU - Ye,Lei, AU - Xie,Saili, Y1 - 2018/12/28/ PY - 2018/12/03/received PY - 2018/12/27/revised PY - 2018/12/27/accepted PY - 2019/1/7/pubmed PY - 2019/7/2/medline PY - 2019/1/7/entrez KW - Dacomitinib KW - Pharmacokinetic profile KW - Plasma KW - UPLC-MS/MS SP - 66 EP - 70 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 166 N2 - Dacomitinib is a highly selective irreversible small-molecule inhibitor of the human epidermal growth factor receptor (HER) family of tyrosine kinases. A simple and quick bioanalytical method was completely developed and validated for the assay and pharmacokinetic investigation of dacomitinib in rat plasma using ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). Proteins in 0.1 mL plasma samples were prepared by precipitant acetonitrile containing ibrutinib as the internal standard (IS). Separation of the analyte from plasma samples was carried out on an Acquity UPLC BEH C18 column using acetonitrile and 0.1% formic acid in water as mobile phase for gradient elution. The total run time and the elution time of dacomitinib were 3.0 min and 1.07 min, respectively. Positive-ion electrospray ionization (ESI) and multiple reaction monitoring (MRM) on a triple quadrupole tandem mass spectrometer were used for detection at the transitions of m/z 470.1 → 124.1 for dacomitinib and m/z 441.2 → 84.3 for ibrutinib (IS), respectively. In the range of 1-150 ng/mL, the calibration curve of dacomitinib was linear with a lower limit of quantitation (LLOQ) of 1 ng/mL. Mean recovery of dacomitinib in plasma was in the range of 76.9-84.1%. The inter- and intra-day precision (RSD) was in the scope of 1.7-8.7% and the accuracy (RE) ranged from -6.1 to 8.5%. Stability studies under different conditions were indicated to be stable. A pharmacokinetic study after oral administration of 40 mg/kg dacomitinib in rats illustrated the applicability of the new presented determination of dacomitinib. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/30612075/Quantitative_bioanalytical_assay_for_the_human_epidermal_growth_factor_receptor__HER__inhibitor_dacomitinib_in_rat_plasma_by_UPLC_MS/MS_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(18)32711-0 DB - PRIME DP - Unbound Medicine ER -