Development and Validation of an Analytical Method for the Assay of Deucravacitinib Tablet Formulation by HPLC

ABSTRACTObjective: The goal of this study was to systematically advance the creation and validation of accurate, repeatable, and preciseHigh-Pressure Liquid Chromatographic techniques for deucravacitinib. Materials and methods: The detector wavelengthwas 240 nm, the rate of flow was 1.0 ml/min, and the mobile phase comprised (ammonium acetate and ACN) (65:35% v/v).The method used the High-Performance Liquid Chromatography technique. Results: The retention time (RT) fordeucravacitinib was 3.699min. It was discovered that the precision was 0.45%. The accuracy results were determined to be(50%-0.1), (100%-0.2), and (200%-0.3). Deucravacitinib has a correlation coefficient of 1. The range of the linearityconcentration was 25–200%. Conclusion: In accordance with ICH Q2(R2), the analytical techniques’ specificity, precision,linearity, accuracy, and robustness were all effectively constructed and validated. The technique was used for routine analysis.