SIMULTANEOUS ESTIMATION OF RABEPRAZOLE SODIUM AND CINITAPRIDE HYDROGEN TARTRATE IN COMBINED PHARMACEUTICAL FORMULATIONAbstract
Three simple, rapid, precise and accurate spectrophotometric methods have been developed for simultaneous analysis of Cinitapride Hydrogen Tartrate (CNT) and Rabeprazole Sodium (RAB) in their combined dosage form. Method A, Simultaneous equation method (Vierodt’s method) applies measurement of absorptivities at two wavelengths, 265.6 nm (λmax of Cinitapride Hydrogen Tartrate) and 282.6 nm, (λmax of Rabeprazole Sodium) in zero order spectra. The concentrations can be calculated from the derived equations. Method B, Q-Absorbance equation method. It involves formation of Q-absorbance equation at 279.00 nm (isoabsorptive point) and 265.60 nm (λmax of Cinitapride Hydrogen Tartrate) in zero order spectra. Method C, Zero crossing first derivative spectrophotometry involves measurement of absorbance at 246.30 nm (for Cinitapride Hydrogen Tartrate) and 304.00 nm (for Rabeprazole Sodium) in first derivative spectra. Developed methods were validated according to ICH guidelines. The calibration graph follows Beer’s law in the range of 4.0 to 20.0 μg/ml for Cinitapride Hydrogen Tartrate and 4.0 to 20.0 μg/ml for Rabeprazole Sodium in water as a solvent with R square value greater than 0.999. Accuracy of all methods was determined by recovery studies and showed % recovery between 98 to 102%. Intraday and inter day precision was checked for all methods and mean %RSD was found to be less than 2 for all the methods. The methods were successfully applied for estimation of Cinitapride Hydrogen Tartrate and Rabeprazole Sodium in marketed formulation.
Vijay Suvagya*, Dillip Kumar Dash and Ashwin Agola
Department of Quality Assurance, N. R. Vekaria Institute of Pharmacy, C. L. College Campus, Bilkha Road, Junagadh-362001, Gujarat, India
04 January, 2013
23 February, 2013
14 April, 2013
01 May, 2013