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

Objectives. - 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. Methods. - 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 1.0 mL/minute, column BDS Hypersil C18 5 mu m 150 x 4.6 mm, column temperature 30 degrees C, injection volume 10 mu L, detection Results. - Calibration charts are acquired in the linearity range (1-30 mu g/mL) of baricitinib with a correlation coefficient = 0.9999 with good recovery results between (99-100%). Conclusion. - 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 (c) 2022 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Automated summary

This study aims to develop a stable RP-HPLC method for determining the content uniformity and in-vitro dissolution of baricitinib and its degradation products in film-coated tablet dosage form. The method has been confirmed by the FDA for the efficacy and safety of baricitinib. The results show that the proposed method has good linearity, accuracy, and recovery, and can effectively determine the content and dissolution of baricitinib and its degradation products.