Abstract
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 m/z 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.
Highlights
Rheumatoid arthritis (RA) is a progressive and long-lasting autoimmune disorder that most commonly affects the joints
The present study aimed to develop a new, rapid, sensitive, reproducible and cost-effective method for determination of baricitinib in plasma and to study its applicability in a pharmacokinetic study in rats
Irbersartan was used as internal standard as it has some physical properties similar to the anayte such as poor solubility in buffer solutions which is essential for separation on HILIC column and was efficiently extracted with the same solvent
Summary
Rheumatoid arthritis (RA) is a progressive and long-lasting autoimmune disorder that most commonly affects the joints. RA is a chronic systemic inflammatory disorder which affects 0.5–1%. It is characterized by persistent inflammation of synovial joints resulting. The mainerosive symptoms of RA are joint pain, cartilage and bone deformity and damage. The main symptoms of RA are joint pain, inflammation, inflammation, swelling, stiffness and generalized fatigue with episodes of RA flares and remissions. Swelling, stiffness disease and generalized fatigue with episodes of RA flares organs, and remissions. RA is a systemic that can have a significant effect on other including heart disease that can have a significant effect on other organs, including eyes [2], heart [3,4], and lung [5].
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