APPLICATION OF MOLECULAR SALT FORMATION REACTIONS OF PICRIC ACID AND CITRIC ACID –ACETIC ANHYDRATE SYSTEM WITH CINITAPRIDE TARTRATE FOR ESTIMATION OF THE DRUG IN BULK AND PHARMACEUTICAL FORMULATIONS

摘要

Objective: The present investigation was aimed at developing and validating two novel highly sensitive, selective, accurate and simple spectrophotometric methods for the determination of Cinitapride tartrate (CNP) in bulk and its dosage forms Methods: Method A was based on molecular salt formation reaction of Cinitapride tartrate with Picric Acid to form a yellow coloured chromogen having absorption maxima of 410 nm*. Method B was based on the formation of an internal salt between Cinitapride tartrate and citric acid –acetic anhydrate system that was measured at 565 nm*. The factors affecting the reaction in both the methods were carefully studied and optimized. The kinetics of the reaction was investigated, and the reaction mechanism was postulated. Results: Under the optimized conditions, linear relationship with good correlation coefficient of was found between the absorbance and Cinitapride tartrate concentration in the range of 8-40 μg / mL and 4-20μg / mL for method A and B respectively. The precision of the method was satisfactory; the values of relative standard deviations did not exceed 1.4%. The proposed method was successfully applied to the determination of Cinitapride tartrate in its bulk form and pharmaceutical formulations with good accuracy. Conclusion: The proposed method was successfully applied to the determination of Cinitapride tartrate in its bulk form and pharmaceutical formulations with good accuracy. Hence, these methods can be used for the routine quality control of CNP in its dosage forms. Keywords: Cinitapride tartrate, Spectrophotometry, Picric Acid, Citric acid – Acetic anhydrate reagent.