Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF TOFACITINIB IN BULK DRUG AND DOSAGE FORM

Dhanashri Lakhe*, Smita Aher, R. S. Bacchav

ABSTRACT

Background:- A new, sensitive, suitable, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of Tofacitinib in bulk drug and tablet formulation was developed and validated in this research. The separation was performed using an HPLC method with a UV detector and Openlab EZchrome workstation programme, Kromasil C18, 250 mm X 4.6mm ID, 5 μm column, Methanol:- Water (60: 40 %V/V) was pumped at a flow rate of 1.0 mL/min and detected at 286 nm. Result:- The developed RP-HPLC method yielded a suitable retention time for Tofacitinib of 3.25 min, which was optimized using trial and error basis. The linearity of the established method was verified with a correlation coefficient (r2) of 0.99999 over the concentration range of 1.0- 15.0 μg / mL . The percentage RSD for the method's precision was found to be less than 2.0 percent. The percentage recoveries were discovered within the limit. 0.073 μg/mL and 0.221 μg/mL were found to be the LOD and LOQ, respectively. Conclusion:- The developed and validated RP-HPLC system takes less time and can be used in the industry for routine quality control/analysis of bulk drug and marketed Tofacitinib products.

Keywords: RP-HPLC, Tofacitinib, Method Development, Validation.