Development of a sensitive spectrophotometric method for determination of the charge-transfer complex of aripiprazole in pharmaceutical formulations: Spectrometric characteristics and analytical applications

This study presents a simple, rapid, and accurate spectrophotometric method for the determination of Aripiprazole (ARP) in tablets. The determination procedure is based on the reaction of ARP with 7,7,8,8-tet racyanoquinodimethane (TCNQ), producing a colored product that was quantitated spectrophotometrically at 392 nm. Various variables affecting the reaction were optimized. The method exhibited a good linearity range with a correlation coefficient of 0.9994, observed as 0.25–3 μg/mL. The developed method was validated according to the International Council for Harmonisation (ICH) guidelines, assessing specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantitation (LOQ). The formation of the CT-complex and the interaction sites were confirmed by elemental analysis, DSC, IR, and 1H NMR spectroscopy. The method was successfully applied to the determination of ARP in pharmaceutical preparation.