UV Spectrophotometric Method for Determination of Cinitapride in Pure and its Solid Dosage Form

B Thangabalan,A Elphine Prabahar,R Kalaichelvi,P Vijayaraj Kumar

doi:10.1155/2009/856537

Abstract

A new, rapid, precise, accurate and sensitive analytical method was developed for the UV spectrophotometric assay of cinitapride (CTP). The drug obeyed the Beer's law and showed good correlation. It showed absorption maxima at 260 nm in methanol. The linearity was observed between 5-40 µg mL-1. The results of analysis were validated by recovery studies. The recovery was more than 99%. The proposed method is the only method available for spectrophotometric determination of the drug. It is simple, precise, sensitive and reproducible and can be used for the routine quality control testing of the marketed formulations.

Highlights

Cinitapride, chemically 4-amino-N-[3-(Cyclohexan-1-yl-methyl)-4-piperidinyl]-2-ethoxy-5nitrobenzamide (Figure 1), is a substituted benzamide gastroenteric prokinetic agent acting via complex, but synergistic effects on serotonergic 5-HT2 and 5-HT4 receptor and dopaminergic D2 receptors in the neuronal synapses of the myenteric plexi1-3
The calibration curve was plotted in the concentration range of 5 to 40 μg mL-1 of CTP in methanol
The residues were washed thoroughly with methanol and further diluted with methanol to 20 μg mL-1 concentration and the absorbance measured at 260 nm against methanol as a blank

Summary

Introduction

Cinitapride, chemically 4-amino-N-[3-(Cyclohexan-1-yl-methyl)-4-piperidinyl]-2-ethoxy-5nitrobenzamide (Figure 1), is a substituted benzamide gastroenteric prokinetic agent acting via complex, but synergistic effects on serotonergic 5-HT2 (inhibition) and 5-HT4 (stimulation) receptor and dopaminergic D2 (inhibition) receptors in the neuronal synapses of the myenteric plexi. No spectrophotometric method has been reported so far. An attempt was made to develop simple and economical spectrophotometric methods with greater precision, accuracy, and sensitivity for the analysis of CTP in tablets. The spectrophotometric measurements were carried out using An Elico UV/Visible double beam spectrophotometer SL-164 with 1 cm matched quartz cells. CTP was tested for purity by measuring its melting point and IR spectra and no impurities were found. Standard stock solution of CTP (1000 μg mL-1) was prepared in methanol. The absorbance was measured at 260 nm against methanol as blank. The calibration curve was plotted in the concentration range of 5 to 40 μg mL-1 of CTP in methanol

Procedure for tablets

Results and Discussion

Conclusions