Abstract

ANALYTICAL METHOD FOR ESTIMATION TOLVAPTAN AND RELATED SUBSTANCES IN DRUG PRODUCT BY REVERSE PHASE HIGH PRESSURE LIQUID CHROMATOGRAPHY

S. Sudhakarreddy and Karavadi Thejomoorthy*

ABSTRACT

The developed method was simple, efficient, economical method for the validation of Tolvaptan and it’s related substances in drug product by reverse phase high pressure liquid chromatography. Separation of Tolvaptan and it’s related substances was performed on Inertsil-ODS 3V,5μ (250 x 4.6 mm ) with mobile phase - A 1 ml H3PO4 Solution in 1000 ml H20 and mobile phase - B ACN: Methanol (90:10) at a flow rate of 1.0 ml/min and eluents were monitored at 254 nm. The retention times of TVP VIII 17.041 min and Tolvaptan 13.964 min respectively and showed a good linearity in the concentration range of 20 – 150 μg/ml for related substances with a correlation coefficient of 0.999 respectively. The Tolvaptan percent recoveries ranged between 98.73 % – 100.30 %. RSD for all Parameters are within the acceptance. The method could be successfully used for the analysis of Tolvaptan and it’s related substances in drug product.

Keywords: Tolvaptan, Validation, US-FDA, HPLC.