UV Spectrophotometric Method for the Estimation of Tolvaptan in Bulk and Pharmaceutical Formulations

The main objective was to develop and validate the UV-spectrophotometric method for the estimation of tolvaptan in bulk and pharmaceutical formulations as per ICH guidelines. The initial stock solution of Tolvaptan was prepared in acetonitrile. The λ_max of tolvaptan was found to be 267 nm it was proved linearity in the concentration range 1–10 μg/ml with a correlation coefficient value of 0.999. The accuracy studies of proposed method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 100.4%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.34 and 0.94 μg/ml, respectively. The % RSD less than 2 which indicates the accuracy and precise of the method. The above method was a rapid tool for routine analysis of tolvaptan in the bulk and in the pharmaceutical dosage form.