Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE IN COMBINED DOSAGE FORM

Dr. T. Charan Singh*

Abstract

Three simple, accurate, rapid and precise uv spectrophotometric methods have been developed for simultaneous estimation of phenylephrine hydrochloride and cetirizine hydrochloride in combined tablet formulation. First Method is dual wavelength method, in which two wavelengths were selected for each drug in a way so that the difference in absorbance is zero for another drug. Cetirizine hydrochloride has equal absorbance at 222.6 nm and 236.4nm. Where the differences in absorbance were measured for the determination of phenylephrine hydrochloride; similarly differences in absorbance at 231.8nm and 260.8nm were measured for the determination of Cetirizine hydrochloride. Second method is mean centering of ratio spectra (MCR) in which absorption spectra of each drug were recorded, divided by suitable divisor and the obtained ratio spectra were mean centered. Third method based upon absorption ratio method which involves measurement of absorbance at 246.0nm (isoabsorptive point) and 230.2nm ( max of cetirizine hydrochloride). These methods were validated as per ICH norms.

Keywords: Dual wavelength method, Mean centering of ratio spectra, Absorbance ratio method, Validation.