Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF FEXOFENADINE HYDROCHLORIDE AND MONTELUKAST SODIUM IN TABLETS

G. Sowjanya* and K. Trideva Sastri

ABSTRACT

The present study describes the development and validation of a simple simultaneous equation method by UV spectrophotometry for estimation of Fexofenadine hydrochloride and Montelukast sodium in bulk and tablets. The maximum absorbance was measured at 259 nm and 344.5 nm for Fexofenadine hydrochloride and Montelukast sodium respectively in 0.1N NaOH. The calibration curves showed a linear relationship between absorbance and concentration in the range of 50-180 μg/ml for Fexofenadine hydrochloride and 1-35 μg/mL for Montelukast sodium with correlation coefficient of 0.998. The method was validated as per ICH guidelines and the outcome of the statistical analysis proved that the method was precise as the relative standard deviation was less than 2.0% for the assay calculated in intraday and interday precision. The mean percentage recoveries of Fexofenadine hydrochloride and Montelukast sodium calculated by standard addition were found to be 101.43 - 100.54% and 99.97-100.2% indicating accuracy of the method. The developed method was also checked in multicomponent mode and the assay values obtained were within the limits. The acceptable results of validation for the present study indicate the suitability of the method for routine quality control analysis of the combined drugs in tablets.

Keywords: Fexofenadine hydrochloride, Montelukast sodium, Simultaneous equation, Validation, ICH guidelines