Analytical Method Development and Validation of Tolvaptan in Bulk and Tablet Dosage Form by RP-HPLC

Abstract

A new, simple, accurate, precise, robust, specific, sensitive and rapid reverse phase high performance
liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of
TOLVAPTAN in pharmaceutical dosage forms. A Nucleosil C18 with mobile phase containing 0.01M
sodium dihydrogen phosphate and acetonitrile in the ratio of 60:40 was used. The flow rate was 0.6 ml / min
and wavelength was monitored at 269 nm. Chromatogram showed the main peak at a retention time of 3.055
min. The developed method was validated according to ICH guidelines and validated fo r linearity,
accuracy, precision, specificity, limit of detection, limit of quantification and robustness. The linearity was
found to be in the range of 25 to 150 mcg / ml. respectively. Recovery of Tolvaptan was found to be in the
range of 99.74-99.87% %.The system precision and method precision was found to be within limits with %
RSD of 0.773 and 0.024% .The developed method was found to be cost effective and was successfully
employed for the determination of the same in various formulations.