Abstract

DEVELOPMENT OF CHROMATOGRAPHIC METHOD AND VALIDATION STABILITY-INDICATING THREE IMPURITIES AND THEIR DEGRADATION PRODUCTS IN TOLVAPTAN TABLETS

P. Vijaya Babu*, Chandra Sekhar, M. Ravi Chandar, K. Sadashiv Patil

Abstract

A Novel RPHPLC Quantification method was developed for estimation of known impurities of Tolvaptan like Amino Hydroxy, Amino and Keto substances 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 and λ max at 240 nm. The developed method validated all the parameters like linearity, specificity, LOD, LOQ, accuracy, robustness, ruggedness, precision, filter variation, solution stability and forced degradation studies.

Keywords: RPHPLC Quantification Method and Validation, Tolvaptan, Forced Degradation Studies, Chromatogram.