Development, validation of liquid chromatographic method for determination of alectinib and characterization of its degradation products

Quality in pharmaceutical products is directly related to the product, and the most important factor determining quality is the analyses performed at various production stages. Quality is similar to the joining of chain links, and any weak link means lack of quality. There are numerous data and recommendations in the literature regarding drug analyses and methods. In this study, an analysis method was proposed for a significant pharmaceutical active ingredient by trying to keep up with the developing analysis techniques. A robust liquid chromatography technique has been established for the analysis of alectinib in pharmaceutical formulations. A three-level Box-Behnken response surface design with the highest affinity was used to optimize the analytical method. The optimized analytical method was validated against ICH guidelines, which include linearity, sensitivity, accuracy and precision, and robustness. Additionally, the sensitivity of the validated method to the degradation products of the active ingredient was confirmed by stress-induced degradation studies. All the degradation products were characterized by LCMS-IT-TOF studies. Additionally, the validated method has been successfully applied to estimate the amount of Alecense® formulation. Moreover, the greenness evaluation of the delevoped method was evaluated using NEMI, Analytical Eco-scale, AGREE and GAPI. No interference of the ingredients of the formulations with the retention times of the active ingredient was observed. development.