Tolvaptan in API and formulation may now be quantifi ed using a technique. The solution was diluted with acetonitrile and scanned in the UV area between 200 and 400 nm. At 267 nm, tolvaptan exhibits maximum absorption. The accuracy investigations had been executed at3 levels, i.e., 80, 100, and 120%, and recuperation turned into discovered to bewith inside the variety of 99.4% for the tolvaptan, which showed linearity over the range of 5 to 160 g/mL with correlation co-effi cient (r2) of 0.9995. The quantifi cation (LoQ) and detection (LoD) threshold were 0.471 and 1.435 g/mL, respectively. The suggested approach underwent forced deterioration, and each parameter’s degradation was discovered. The ICH rules were followed in the validation of each parameter.