A New Approach for Analytical Method Development and Validation for Quantification of Tolvaptan Using RP-HPLC in Bulk and in its Tablet

Abstract

By Using RP-HPLC it was feasible to construct a Quick, Precise, and Accurate Approach for the measurement of Tolvaptan in Bulk and Pharmaceutical Dosage form. In order to do the chromatography, the stationary phase PhenomenoxC18 100 mm x 4.6 mm, 5µmcolumn system was used for UV detection with a267 nm wavelength. The mobile phase was GAA (60:40) with water (HPLC grade) adjusted topH-3 at a flow rate of 0.6 ml/min. A retention time of 3.4 minutes was observed for tolvaptan. ICH Q2 (R1) guidelines were followed to approve the developed procedure. The approach produces linear responses 25-150. There aren’t many liquid chromatographic methods that have been published to determine tolvaptan. As a result, the current approach, which was created and validated using RP-HPLC, would be a quick, precise, and accurate way to measure tolvaptan in pharmaceutical dosage forms and bulk.