DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF CINITAPRIDE IN PURE AND IN ITS PHARMACEUTICAL FORMULATION

摘要

Two simple, sensitive, accurate and economical spectrophotometric methods (A and B) were developed for the determination of cinitapride in pure and in pharmaceutical formulation. Method A is based on the reaction of the nitro group of the drug with potassium hydroxide in dimethyl sulphoxide medium to form a colored product, which shows absorbance maximum at 401 nm. Method B is based on the diazotization of cinitapride with nitrous acid to form diazotized cinitapride, followed by its coupling with β-naphthol to form a red colored chromogen which shows maximum absorption at 552 nm. Beer’s law is obeyed in the concentration range of 10–50 μg mL–1 for method A and 1-5 μg mL–1 for method B. Correlation coefficient was found to be 0.999 for both methods. The methods have been successfully applied for the assay of the drug in pure and in pharmaceutical formulation. No interference was observed from common pharmaceutical additives. The developed methods were validated respect to linearity, precision, LOD, LOQ and accuracy.