RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ALECTINIB FOR THE ESTIMATION OF API AND PHARMACEUTICAL FORMULATION

A simple and efficient isocratic reversed-phase HPLC method for the quantitative estimation of Alectinib in bulk drug and pharmaceutical formulations has been developed and validated as per ICH guidelines. The method demonstrated excellent linearity, accuracy, precision, specificity, and system suitability. Validation studies confirmed no interference from excipients, with the recovery studies showing high accuracy. The method exhibited low %RSD, suggesting high precision and sensitivity, and was proven to be robust under varying conditions such as flow rate and mobile phase composition. The proposed method is rapid, cost-effective, and environmentally friendly due to lower solvent consumption. Statistical analysis indicated no significant difference in the results, affirming the reliability of the method. This HPLC method can be used for routine quality control analysis of Alectinib in both bulk manufacturing and marketed dosage forms.

Keywords: Alectinib, RP-HPLC, Method Development, Method Validation, Accuracy, Precision, Specificity, ICH Guidelines.