Analytical Method Development and Validation of RP-HPLC for The Quantitative Determination of Baricitinib in Pure Substances and Marketed Formulation (Research Article)

Author(s): Santhosh Illendula* and Peddaboina Shiva Prasad

Abstract: An accurate, precise and rapid RP-HPLC method was developed and subsequently validated for the determination of Baricitinib in bulk form and marketed pharmaceutical dosage form. Better separation of the drug was achieved on Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. with the mobile phase consisted of mixture of Methanol and Phosphate buffer (0.02M, pH-3.6) in ratio of 45:55v/v at flow rate of 1.0ml/min, with detection at 255nm using UV detector. The retention time was found to be 3.254min. The method was found to be linear in the range of 12-28μg/ml with a correlation coefficient (r2) of 0.9995. The LOD and LOQ of the method were calculated to be 5.004 and 15.164μg/ml respectively. The Precision was estimated by employing repeatability; intra-day and inter-day studies and the results were calculated as %RSD values and were found to be within the limits. Recovery of Baricitinib was found to be in the range of 98-102-% which confirms the accuracy of the method. The proposed HPLC method is validated using standard ICH guidelines.

PAGES: 108-114  |  27 VIEWS  36 DOWNLOADS