Validated stability indicating chromatographic method for determination of baricitinib and its degradation products in their tablet dosage form: Implementation to content uniformity and in vitro dissolution studies

Abstract

Newly, baricitinib (Olumiant) is FDA-confirmed for treating adult patients with slightly to highly active rheumatoid arthritis who have a terrible reaction to several treatments against the tumor necrosis factor. The efficacy and safety of baricitinib have been determined by the FDA, so, a precise, and sensitive stability-indicating RP-HPLC method is issued to determine baricitinib and its degradation products in their film-coated tablet dosage form; application to content uniformity and in-vitro dissolution studies. The analysis of assay and dissolution tests are released using an isocratic elution system while impurities are performed using gradient profile for mobile phase comprising of Buffer Solution: Methanol in Proportion (65:35, v/v) at flow rate 1.0mL/minute, column BDS Hypersil C18 5μm 150×4.6mm, column temperature 30̊C, injection volume 10μL, detection wavelength 290nm using DAD detector. Calibration charts are acquired in the linearity range (1-30μg/mL) of baricitinib with a correlation coefficient=0.9999 with good recovery results between (99-100%). The proposed procedure was fully validated regarding Linearity, Accuracy, LOD, LOQ, Precision, Robustness, and Specificity, and there is no overlapping owing to deterioration peaks. Furthermore, the method has been accomplished to study content uniformity testing and in-vitro dissolution.