Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies

Tolvaptan in bulk and formulation in spiking human plasma were estimated using a brand-new, straightforward, speedy, precise, and accurate bioanalytical method that was developed and validated using UV-visible spectrophotometer. The acetonitrile-based solvent chosen for the tolvaptan UV study was scanned over the UV spectrum from 200 to 400nm using a solution containing 10g/ml. At 267nm, Tolvaptan exhibits its greatest absorption. The accuracy investigations were conducted at three distinct levels, i.e., 80%, 100%, and 120%, and recovery was found to be in the range of 99.4%. The tolvaptan showed linearity over the range of 5-160g/mL with correlation coefficientnt (r2) of 0.999. The thresholds for detection and quantification were 0.471 and 1.435 g/ml, respectively. In accordance with ICH requirements, all the parameters were validated.