STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RUXOLITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM USING UPLC

Abstract

Objective: To establish a simple and selective UPLC (Ultra-high Performance Liquid Chromatography) method for the determination of Ruxolitinib in tablet and bulk dosage forms.  Methods: Chromatographic separation was achieved on a C8 column with the dimensions of (250×4.6m ID) 5 µm length; the mobile phase composition was a mixture of pH 6.2 with glacial acetic acid: Methanol: acetonitrile in the ratio of 40:30:30 was passed through the designated column with a flow rate of 1 ml per minute and the UV (Ultra Violet) detection was witnessed at 254 nm.  Results: Linearity was observed in the range 50-150 µg/ml for Ruxolitinib (r² =0.9998) for drugs estimated by the proposed methods was in good agreement with the label claim. The % recovery of the drug was found to be between 98 and 102%. The drug was used for determining stability studies for acid, alkali, thermal, photolytic, and peroxide degradation. Conclusion: The method for determining Ruxolitinib was discovered to be simple, precise, accurate, and high resolution, with a shorter retention time, making it more acceptable and cost-effective for routine analysis.