UV spectrophotometric methods for quantitative determination of masitinib; extraction of qualitative information

Abstract

Masitinib is an orally administered selective tyrosine kinase inhibitor. It has emerged as a promising drug for multiple diseases including cancer and inflammation in either human or veterinary medicine. Five new and simple UV spectrophotometric methods were developed for its determination in bulk and in pharmaceutical tablets. These methods are based on measuring the absorbance of masitinib in either zero order or first, second, third or fourth derivative spectra. Measurements are optimized so as to minimize excipients' interferences. The methods are suitable for micro-analysis of masitinib. The proposed methods were validated according to the ICH-Q2(R1) guidelines and was successfully applied for determination of masitinib in laboratory prepared tablet. The presented methods are simple, fast, cost‐effective and suitable for routine pharmaceutical analysis. Moreover, two derivative spectrophotometric-based methods were developed for identification of masitinib, the derivative ratio method and log-A derivative method. The impact of the developed methods on the environment was assessed by both analytical Eco-Sale and the Green Analytical Procedure Index (GAPI). The present work proves how derivative spectrophotometry could greatly extract qualitative and quantitative information from UV spectra.