Validated spectophotometric methods for the assay of cinitapride hydrogen tartrate in pharmaceuticals

Abstract

Three simple, selective and rapid spectrophotometric methods have been established for the determination of cinitapride hydrogen tartrate (CHT) in pharmaceutical tablets. The proposed methods are based on the diazotization of CHT with sodium nitrite and hydrochloric acid, followed by coupling with resorcinol, 1-benzoyiacetone and 8-hydroxyquinoline in alkaline medium for methods A, B and C, respectively. The formed azo dyes are measured at 442, 465 and 552 nm for methods A, B and C, respectively. The parameters that affect the reaction were carefully optimized. Under optimum conditions, Beer’s law is obeyed over the ranges 2.0-32.0, 1.0-24.0 and 1.0-20.0 µg mL-1 for methods A, B and C, respectively. The calculated molar absorptivity values were 1.2853x104, 1.9624x104 and 3.92x104 L mol-1 cm-1 for methods A, B and C respectively. The results of the proposed procedures were validated statistically according to ICH guidelines. The proposed methods were successfully applied to the determination of CHT in Cintapro tablets without interference from common excipients encountered.