Development and Validation of RP HPLC Method for Estimation of Ruxolitinib Tablet in Pharmaceutical Dosage Form

Abstract

HPLC is a separation technique used to conduct chromatography. There are various technologies of chromatography in which RP-HPLC is one of them. Reverse phase HPLC is highly valuable in research technique because it uses water based mobile phase in organic solvent. Ruxolitnib is a JAK ½ inhibitor used in the treatment of myelofibrosis. Ruxolitinib gives highly separation in RP-HLPC method. So using this method gives marvelous result with help of different ingredients.(RP-HPLC) method was developed for the quantification of Ruxolitinib zorbax SB (Stable bond) C18 phenyl (150×4.6mm 3.5μm) column was used as stationary phase to separate drug. Mobile phase comprised of ACN: MeOH (50:50) having pH 3.5was run isocratically at a flow rate of 1mL/min at 35ºC. The method was validated according to ICH guidelines for linearity, precision, accuracy,. The method was found accurate, precise with average retention time 15min with regression coefficient R2 value of 0.9996 as per ICH norms, the developed method was successfully validated and used for the quantification of Ruxolitinib in fast dissolving tablets.