A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats
Baricitinib, is a selective and reversible Janus kinase inhibitor, is commonly used to treat adult patients with moderately to severely active rheumatoid arthritis (RA). A fast, reproducible and sensitive method of liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the quantification of b...
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MDPI AG
2020-03-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/25/7/1600 |
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| author | Essam Ezzeldin Muzaffar Iqbal Yousif A. Asiri Azza A Ali Prawez Alam Toqa El-Nahhas |
| author_facet | Essam Ezzeldin Muzaffar Iqbal Yousif A. Asiri Azza A Ali Prawez Alam Toqa El-Nahhas |
| author_sort | Essam Ezzeldin |
| collection | DOAJ |
| description | Baricitinib, is a selective and reversible Janus kinase inhibitor, is commonly used to treat adult patients with moderately to severely active rheumatoid arthritis (RA). A fast, reproducible and sensitive method of liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the quantification of baricitinib in rat plasma has been developed. Irbersartan was used as the internal standard (IS). Baracitinib and IS were extracted from plasma by liquid–liquid extraction using a mixture of n-hexane and dichloromethane (1:1) as extracting agent. Chromatographic separation was performed using Acquity UPLC HILIC BEH 1.7 µm 2.1 × 50 mm column with the mobile phase consisting of 0.1% formic acid in acetonitrile and 20 mM ammonium acetate (pH 3) (97:3). The electrospray ionization in the positive-mode was used for sample ionization in the multiple reaction monitoring mode. Baricitinib and the IS were quantified using precursor-to-production transitions of <i>m</i>/<i>z</i> 372.15 > 251.24 and 429.69 > 207.35 for baricitinib and IS, respectively. The method was validated according to the recent FDA and EMA guidelines for bioanalytical method validation. The lower limit of quantification was 0.2 ng/mL, whereas the intra-day and inter-day accuracies of quality control (QCs) samples were ranged between 85.31% to 89.97% and 87.50% to 88.33%, respectively. Linearity, recovery, precision, and stability parameters were found to be within the acceptable range. The method was applied successfully applied in pilot pharmacokinetic studies. |
| first_indexed | 2024-03-10T20:46:47Z |
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| language | English |
| last_indexed | 2024-03-10T20:46:47Z |
| publishDate | 2020-03-01 |
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| series | Molecules |
| spelling | doaj.art-4f31f7fbc22848a7954d92839b2cbd312023-11-19T20:16:05ZengMDPI AGMolecules1420-30492020-03-01257160010.3390/molecules25071600A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in RatsEssam Ezzeldin0Muzaffar Iqbal1Yousif A. Asiri2Azza A Ali3Prawez Alam4Toqa El-Nahhas5Department of Pharmaceutical Chemistry and Drug Bioavailability Unit, Central Laboratory, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutical Chemistry and Drug Bioavailability Unit, Central Laboratory, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaClinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh 11451, Saudi ArabiaPharmacology and Toxicology Department, Faculty of Pharmacy (Girls) Al-Azhar University, Cairo 11754, EgyptPharmacognosy Department, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi ArabiaPharmacology and Toxicology Department, Faculty of Pharmacy (Girls) Al-Azhar University, Cairo 11754, EgyptBaricitinib, is a selective and reversible Janus kinase inhibitor, is commonly used to treat adult patients with moderately to severely active rheumatoid arthritis (RA). A fast, reproducible and sensitive method of liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the quantification of baricitinib in rat plasma has been developed. Irbersartan was used as the internal standard (IS). Baracitinib and IS were extracted from plasma by liquid–liquid extraction using a mixture of n-hexane and dichloromethane (1:1) as extracting agent. Chromatographic separation was performed using Acquity UPLC HILIC BEH 1.7 µm 2.1 × 50 mm column with the mobile phase consisting of 0.1% formic acid in acetonitrile and 20 mM ammonium acetate (pH 3) (97:3). The electrospray ionization in the positive-mode was used for sample ionization in the multiple reaction monitoring mode. Baricitinib and the IS were quantified using precursor-to-production transitions of <i>m</i>/<i>z</i> 372.15 > 251.24 and 429.69 > 207.35 for baricitinib and IS, respectively. The method was validated according to the recent FDA and EMA guidelines for bioanalytical method validation. The lower limit of quantification was 0.2 ng/mL, whereas the intra-day and inter-day accuracies of quality control (QCs) samples were ranged between 85.31% to 89.97% and 87.50% to 88.33%, respectively. Linearity, recovery, precision, and stability parameters were found to be within the acceptable range. The method was applied successfully applied in pilot pharmacokinetic studies.https://www.mdpi.com/1420-3049/25/7/1600baricitinibUPLC-MS/MSpharmacokinetic studyirbersartan |
| spellingShingle | Essam Ezzeldin Muzaffar Iqbal Yousif A. Asiri Azza A Ali Prawez Alam Toqa El-Nahhas A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats Molecules baricitinib UPLC-MS/MS pharmacokinetic study irbersartan |
| title | A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats |
| title_full | A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats |
| title_fullStr | A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats |
| title_full_unstemmed | A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats |
| title_short | A Hydrophilic Interaction Liquid Chromatography–Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats |
| title_sort | hydrophilic interaction liquid chromatography tandem mass spectrometry quantitative method for determination of baricitinib in plasma and its application in a pharmacokinetic study in rats |
| topic | baricitinib UPLC-MS/MS pharmacokinetic study irbersartan |
| url | https://www.mdpi.com/1420-3049/25/7/1600 |
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