Author: Kiran Kumar Gannamani and Sudhakar Chintakula

DOI: http://doi.org/10.31788/RJC.2023.1638344

The current study aims to develop a method for determining Baricitinib along with its related compounds, as well as to confirm its stability under various circumstances and forced degradation methods using reverse-phase HPLC. The separation was performed using an inert-sustain C8 column that is with a 4.6 mm internal diameter, 250 mm long, which is loaded with Octyl silane chemically bound to porous silica particles of 5 μm diameter, with a flow rate of 1 ml per minute, UV detection of 225 nm, and a column oven temperature of 45 °C. The total time required to acquire data was fifty minutes. The test method has been validated and shown to be accurate in terms of specificity, precision (system, method, and intermediate precision), linearity, the limit of detection (LoD) and limit of quantitation (LoQ), accuracy, range, stability of mobile phase, standard and sample solutions, and system suitability. For the purpose of identifying related compounds in Baricitinib drug material, the devised test method is appropriate and can be used routinely.

Keywords: Degradation, Method Development, Impurities, RP-HPLC, Baricitinib, Validation, Stability.