A New Stability Indicating High Performance Liquid Chromatography Method for the Estimation of Ruxolitinib in Bulk and Tablet Dosage Form

Abstract

Background: The present research work described about the systemic development of High-Performance Liquid Chromatography (HPLC) method for the quantitative determination of ruxolitinib in bulk and tablet dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with a HPLC (Waters-717 series) Symmetry ODS RP C18, 250mm x 4.6mm.i.d., 5μm,column with an isocratic mobile phase containing a mixture of acetonitrile: methanol: 1% Ortho phosphoric acid in the volume ratio of 70:25:5. The flow rate of the mobile phase was 1 ml/min and detection wavelength at 258 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 5 to 200μg/ml with a correlation coefficient of 0.9997. The recovery of ruxolitinib was found to be in the range of 98 to 101%, whereas the detection limits were found to be 0.09 and quantitation limit was 0.29 μg/ml. Forced degradation study reveals its higher degradation at thermal and peroxide conditions in compare to other degradation condition. Conclusion: The present method was validated according to the ICH guidelines and it is applied successfully for the determination of ruxolitinib in tablets.