ICH Guideline in Practice for Quantification of Ruxolitinib by applying Validated RP-HPLC Method on Commercial Tablet Formulation

Abstract

Background: The current investigation explains the validation of High Pressure Liquid Chromatography (HPLC) technique for quantification of Ruxolitinib in active ingredient and marketed tablet dosage form. For assessment of Ruxolitinib, a specific column chromatographic method has been developed using UV detection. Methods: The chromatographic elution was executed on ODS Phenomenex analytical column (250mm × 4.6mm, 5μm particle size). The solvent ratio utilized was methanol: water (pH 3.5 adjusted with OPA) (70:30 V/V). A constant ratio of eluting phase flow rate 1.0ml/min was used to detect RTB at 236nm. Results: The developed method was justified using various variables such as accuracy, limit of detection, precision, specificity, robustness, limit of quantification. The retention time for Ruxolitinib was obtained at 8.59 min. The designed method was detected linear within 20 to 120μg/ml range. Correlation coefficient (r2) of the regression equation was found to be 0.9999. Detection and quantitation limit achieved was 0.1496 and 0.4483 respectively. The accuracy of the method was determined using recovery study. The % recovery obtained was in the range of 98.68 – 99.80%. All system suitability factors like tailing factor, retention factor, number of theoretical plates were obtained within acceptance range. The obtained result demonstrates that the presented method is reliable, precise, and economical. Conclusion: The specified method was effectively authenticated as per guidelines of ICH in practice and can be claimed successful for the determination of Ruxolitinib in commercial formulation. © RJPT All right reserved.