Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies Bhavyasri K.1,*, Aishwarya B.2, Suchitra D.3, Sumakanth M.4 1Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad, 500027 2Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad, 500027 3Department of Pharmaceutical Analysis, Vision College of Pharmaceutical Sciences and Research, Boduppal, Hyderabad 4Department of Pharmaceutical Chemistry, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad, 500027 *Corresponding Author E-mail: bhavya.khagga@gmail.com
Online Published on 07 February, 2024. Abstract 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. Top Keywords Bioanalytical method development, Tolvaptan, UV-visible spectrophotometer, Validation, Liquid-Liquid Extraction. Top |