Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry

The primary aim of the current investigation was the Analytical progression and validation of a UV-spectrophotometric analytical approach for the quantification of Nirogacestat in both bulk and pharmaceutical dosage forms, in alignment with ICH regulatory standards. A straightforward, expeditious, reliable, and economically viable UV-spectrophotometric technique was established for the quantitative determination of Nirogacestat employing acetonitrile as the solvent medium. The absorbance of the analyte solution was recorded at 269 nm relative to a suitable blank. Method validation was performed pursuant with prescribed parameters, encompassing linearity, accuracy, precision and robustness. The λmax of Nirogacestat in acetonitrile was identified at 269 nm. The analyte demonstrated compliance with Beer-Lambert’s law across the concentration interval of 2.5–15.0 μg/mL, exhibiting a correlation coefficient(R²) of 0.999. The percentage recovery ranged from 99.3% to 100.1% reflecting substantial accuracy. Precision assessments resulted %RSD values below 2.0, substantiating both repeatability and intermediate precision. Robustness evaluations involving minor alterations in wavelength exhibited negligible deviation, thereby affirming reliability. Additionally, forced degradation experiments substantiated the stability-indicating characteristics. The delineated UV-spectrophotometric technique is straightforward, analytically sensitive, and reproducible. It is eminently suitable for routine quality assessment and quantitative evaluation of Nirogacestat in bulk drug substances and tablet formulations.