Development and Validation of Colorimetric Methods for the Determination of Cinitapride Hydrogen Tartarate in Pure Drug and its Pharmaceutical Formulations

摘要

Two simple, sensitive and highly accurate UV spectrophotometric methods (A and B) have been developed for the determination of Cinitapride Hydrogen Tartarate in pure drug and its pharmaceutical formulations. Method A is based on the diazotization of CHT with nitrous acid to form diazotized CHT, followed by its coupling with β-Naphthol to form red coloured chromogen, which shows absorption maximum at 552 nm and obeys beers law on the concentration range of 1-5 μg/mL. Method B is based on the diazotization of CHT with nitrous acid to form diazotized CHT, followed by its coupling with Chromotropic acid to form pink coloured chromogen which shows maximum absorption at 511 nm and obeys beers law in the concentration range of 4-20 μg/mL. The methods have been successfully applied for the assay of drug in pure and in pharmaceutical formulation. No interference was observed from common pharmaceutical additives. The developed methods were validated by determining its sensitivity, accuracy and precision as per ICH guidelines.