Green Chemistry Method Based on Native Fluorescence for Estimation of Recently Approved Anti-neoplastic Drug Sotorasib

Abstract

Abstract A new, simple, green and highly sensitive method has been established for quantification of recently approved antineoplastic drug Sotorasib (SOTO) in its bulk, tablets and biological fluids. The method depends on measuring the intrinsic fluorescence of the studied drug at wavelengths 350/410 nm at the optimal conditions. Validation of this method was performed following the guidelines of ICH. The proposed method shows linearity over a range of concentration 0.1-1.0 µg mL-1 with detection and quantification limits of 0.028 and 0.89 µg mL-1 respectively. Due to its high sensitivity, the suggested method was applied for quantification of the cited drug in spiked plasma and urine. The suggested strategy was also applied to evaluate the content uniformity in commercial tablets following the USP guidelines.