Abstract

Stability indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of tolvaptane. All the drugs were separated on ODS 250x 4.6 mm, 5m. The mobile phase was a 60:40 (v/v) mixture of acetonitrile and 0.1%orthophosphoric acid buffer, pumped at a flow rate of 1 ml/min. UV detection was performed at 270 nm. The retention time of tolvaptane was found to be 2.594 min respectively. The method was validated in the sample concentration ranges of 25-150µg/ml for tolvaptane. The method demonstrated to be robust, resisting to small deliberate changes in pH and flow rate of the mobile phase. The LOD values were 0.14 µg/ml, while the LOQ values were 0.43 µg/ml for tolvaptane.

Keywords

RP-HPLC, Tolvaptane, Tablet Dosage Form, Forced Degradation

Cite This Article

Ganipisetty, L.A., Dachinamoorthy, D., Rao, S. (2015). A New Stability Indicating RP-HPLC Method Development and Validation for the Estimation of Tolvaptane with Forced Degradation Studies in Bulk and Tablet Dosage Form, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(2), 250-257.