Stability Indicating Method Development and Validation of Baricitinib in Bulk and Formulation Using UV Spectroscopy

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Baricitinib is a novel drug that was approved for use in treating moderate to severe rheumatoid arthritis, and severe alopecia areata. It also became the first immunomodulatory drug to get FDA approval in 2022 for treating COVID-19 in hospitalized adults requiring supplemental oxygen. It is a selective JAK inhibitor that binds reversibly and inhibits Janus Kinase 1 and Janus Kinase 2. The present study aimed to develop a method to demonstrate the stability and validation of baritinib in bulk and formulation using UV spectroscopy. A simple, precise, and economical method has been developed for the estimation of baricitinib in bulk and formulation. The UV spectroscopic method was developed using DMF (Dimethylformamide) and distilled water as the diluent. The standard stock solution for the UV spectroscopic method was prepared by dissolving 10 mg drug in 1 mL DMF and later made up with distilled water. The subsequent dilutions were prepared using distilled water and the dilutions were quantified at 309 nm. The method was validated according to the ICH guidelines Q2 R (2). Linearity was found to be in the concentration range of 10-100 μg/mL with a good correlation coefficient (r²) of 0.999. The precision was found to be within the acceptable limits (%RSD < 2.0). Therefore, the method developed is sensitive, reproducible, and precise, and can be used as the routine quality control test for baricitinib.