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

Author(s)

Ganipisetty, L.A., Dachinamoorthy, D., Rao, S.

Author's Affiliation

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.