DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF BARICITINIB IN BULK DRUG AND DOSAGE FORM
Aniket Shewale*, Smita Aher and Rushikesh Bachhav
ABSTRACT
Background:- A new, sensitive, suitable, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of Baricitinib 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 251 nm. Result:- The developed RP-HPLC method yielded a suitable retention time for Baricitinib of 3.05 min, which was optimized using trial and error basis. The linearity of the established method was verified with a
correlation coefficient (r2) of 0.9999 over the concentration range of 1.0- 15μg/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. 0.063 μg/mL and 0.191 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 Baricitinib products.
Keywords: RP-HPLC, Baricitinib, Method Development, Validation.
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