Abstract

A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PRALSETINIB BY UV SPECTROSCOPIC METHOD

Dr. Santhosh Illendula*, Chinta Gowtham, Kodigela Sreeja, Nallabothula Sandhya, Singireddy Akanksha, Kurthi Manasa, Sunnapu Shiva, Dr. Suthakaran Raj

Abstract

A new simple, accurate, rapid, precise and reproducible spectrophotometric method for the quantitative estimation Pralsetinib in bulk form. The developed visible spectrophotometric method for the quantitative estimation of Pralsetinib is based on measurement of absorption at maximum wavelength 260 nm using with Orthophosphoric acid: Acetonitrile (60:40 v/v) as a solvent. The stock solution of Pralsetinib was prepared, and subsequent suitable dilution was prepared in diluent to obtained standard curve. The standard solution of Pralsetinib shows absorption maxima at 260 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 0.9999 at 260 nm. The overall % recovery was found to be 99.64% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.4499 and 0. 7497, respectively which is

Keywords: Pralsetinib, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Acetonitrile, Orthophosphoric acid, Accuracy, Precision.