Abstract

CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION STABILITY-INDICATING ONE IMPURITY AND ITS DEGRADATION PRODUCTS IN RUFINAMIDE ORAL SUSPENSION 40MG/ML

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

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Abstract

A Novel RPHPLC Quantification method was developed for estimation of Rufinamide known impurities like its Acid impurity, were separated on Kinetex C18, 250 x 4.6 mm, 5.0 μm. Using a mixture of Mobile phase-A: Phosphate Buffer pH 4.0 and Mobile phase-B: Tetrahydrofuran/MeOH/ACN/Water = 200/300/300/200 (v/v/v/v) as a gradient mobile phase with a flow rate of 1.0 ml/min; λ max at 215 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, Rufinamide, Related substances, Stability-indicating, Oral solution.