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

Authors

DOI:

https://doi.org/10.22159/ijpps.2023v15i2.46839

Keywords:

Ruxolitinib, UPLC, Linearity, Chromatographic separation high resolution, Shorter retention, Stability studies

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.

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Published

01-02-2023

How to Cite

TABASSUM, R., and S. H. RIZWAN. “STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RUXOLITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM USING UPLC”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 15, no. 2, Feb. 2023, pp. 40-46, doi:10.22159/ijpps.2023v15i2.46839.

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