Abstract

CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION STABILITY-INDICATING TWO IMPURITIES AND ITS DEGRADATION PRODUCTS IN TOFACITINIB ORAL SOLUTION 1MG/ML

*M. Naresh Chandra Reddy, K. B. Chandra Sekhar and A. Kavitha

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Abstract

A Novel RPHPLC Quantification method was developed for estimation of Tofacitinib known impurities like its Amine impurity and Metabolite-1which, were separated on Waters Sunfire®C18, 50 x 4.6 mm, 5 μm (Part No.: 186002560). Using a mixture of Mobile phase- A: Buffer Solution pH 5.5/Acetonitrile = 90/10 (v/v) and Mobile phase-B: Acetonitrile/Buffer Solution pH 5.5 = 70/30 (v/v) as a gradient mobile phase with a flow rate of 1.2 ml/min; λ max at 210 nm. The developed method was validated all the parameters like linearity, specificity, LOD, LOQ, accuracy, robustness, ruggedness, precision, filter variation, solution stability and forced degradation studies.

Keywords: Method development and validation, Tofacitinib, Related substances, Stability-indicating, Oral solution.