METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TOFACITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Dr. Narasimha Rao B. V.*, Dr. Prasada Rao M., Udaya Krishna Veni A., Lavanya D., Ambika G., Manasa J., Dharshan M., Swetha M.

This work developed and validated a reverse phase high performance liquid chromatography method for estimating tofacitinib in bulk and pharmaceutical formulations. In statistically planned studies, a number of method aspects were changed, such as mobile phase ratio and column type, to assess how these factors affected the chromatographic separation of tofacitinib. The separation was carried out on a Phenyl HexylColumn (150 x 4.6 mm and 5µm) at room temperature under isocratic conditions at a flow rate of 1.0 mL/min using 0.1% formic acid pH 2.9: Acetonitrile in a ratio of 50:50 (v/v). A PDA detector operating at 287 nm for a total of 6 minutes made the detection with the retention time of 3.521 minutes. Calibration curves were linear between 2.75 and 16.5 μg/mL. The calculated LOQ of 0.98μg/mL and the observed LOD of 0.32μg/mL show how sensitive the developed technique is. The %RSD being less than 2 validated the robustness and ruggedness of the approach. The assay % for formulation analysis was 99.36. Consequently, this method was frequently used to analyze tofacitinib in bulk and pharmaceutical formulations.