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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BILASTINE AND MONTELUKAST SODIUM BY UV SPECTROPHOTOMETRY

R. Mohan Raj*, A. S. K. Sankar and T. Vetrichelvan

ABSTRACT

A new, simple, precise, sensitive and specific UV spectrophotometric method was developed for the simultaneous estimation of Bilastine and Montelukast Sodium in bulk and in tablet dosage form. The wavelength maxima (λmax) for Bilastine were 214 nm Montelukast Sodium were found to be 281nm in methanol. The linearity for this method was found to be in the range of 4-20 μg/ml and 2-10μg/ml for Bilastine and Montelukast sodium. The correlation coefficient (r) was found to be of 0.9992 and 0.9996 for Bilastine and Montelukast sodium. This sensitive method was capable to recover accurately and precisely from 50 %, 100 % and 150 % level of target concentration. The proposed method may be suitably applied for the analysis of Montelukast Sodium in bulk and in tablet pharmaceutical formulation for routine analysis. The method was validated as per ICH Guidelines.

Keywords: Bilastine, Montelukast sodium, UV-Spectrophotometry, Simultaneous Equation.


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