DEVELOPMENT AND VALIDATION OF NOVEL STABILITY INDICATING RP-HPLC METHOD FOR QUANTIFICATION OF TOLVAPTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Specific stability-indicating reversed-phase high performance liquid chromatography (HPLC) method has been developed and validated for the quantification of tolvaptan in bulk drug and pharmaceutical dosage form. The optimized conditions for the developed HPLC method are; Inertil ODS-3V column (150 x 4.6 mm, 5.0 mm) maintained at 30°C with mobile phase consisting of 0.1% ortho phosphoric acid and acetonitrile in the ratio 40:60%v/v on isocratic mode at flow rate of 1.0 mL/min and detection wavelength 254 nm. The retention time of tolvaptan was found to be 2.59 min with linearity in the concentration range from 37.5 – 225.0 µg/mL, respectively. The mean percentage recovery of tolvaptan was found to be 98.30 – 101.13 %, respectively. The percent relative standard values were less than 2.0 at all the levels and indicates a satisfactory accuracy and precision. The robustness of the method found to meet the acceptance criteria. The stress study against qualified working standard of Tolvaptan, indicated that the developed HPLC method was stability- indicating, conducted as per ICH requirements. The developed method can be handy in the quality control of bulk and pharmaceutical dosage forms.