Abstract

CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION STABILITY-INDICATING THREE IMPURITIES AND ITS DEGRADATION PRODUCTS IN TOLVAPTAN 15/30MG TABLETS

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 Tolvaptan known impurities like its Amino Hydroxy, Amino and Keto which, were separated on Phenomenex Kinetex C18 column (75 mm x 4.6 mm; 2.6μ). Using a mixture of phosphate buffer, Acetonitrile and Methanol as a gradient mobile phase with a flow rate of 1.0 ml/min; λ max at 240 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, Tolvaptan, Related substances, Stability-indicating, Tablets.