Development and validation of Novel drug RP-HPLC method for quantification of Tolvaptan bulk and Pharmaceutical dosage form. (KEY IJP************958)

• M Ashok Babu

Abstract

A method was set up for synchronous estimation of a Tolvaptan by RP-HPLC. This was simple, rapid, effective and efficient technique for the validation of Tolvaptan in bulk and Pharmaceutical dosage form by RP-HPLC. A Thermosil C18 Column (100mm x 4.6mm) 5m in isocratic mode, with mobile phase was Phosphate buffer: Methanol pH 2.5 (35:65 vv) were used. The flow rate was 1mlmin. UV recognition at 254 nm. The correlation coefficient is 0. 999.The method was validated for system suitability, Linearity, precision, accuracy, ruggedness, robustness, LOD & LOQ. The recovery studies were found to be in the range 99.1-100.11% and showing linearity in the range of 20-60gml. Proposed method can be successfully applied for the quantitative determination for Tolvaptan in Bulk and Pharmaceutical dosage form