Q Analysis of Montelukast Sodium and Fexofenadine Hydrochloride in Tablet Formulation by Derivative Spectrophotometry

Objective: The aim of this study is to present the simple and sensitive method for the analysis of montelukast and fexofenadine hydrochloride and apply the proposed method for the analysis of said drugs in pharmaceutical dosage forms. Methods: Montelukast and fexofenadine hydrochloride are used in combination for management of allergy. The procedure of the first order derivative spectrophotometry allowed simultaneous determination of montelukast sodium and fexofenadine hydrochloride in fixed dose combination product. Results: The method employed first order derivative spectroscopy for estimation of λmax by taking 10 μg/ml each of montelukast sodium and fexofenadine hydrochloride were scanned in 200-400 nm range. The absorbance values at 340 nm and 212.6 nm of the first derivative spectrum was used for the determination of montelukast and fexofenadine hydrochloride respectively without related interference. Conclusion: This method obeyed Beer's law in the concentration range of 4-24 μg/ml for montelukast and 4-24 μg/ml for fexofenadine hydrochloride . The results of analysis have been validated statistically and recovery studies established the accuracy of the proposed method and low values of standard deviation confirmed correctness of the used method. The method was validated as per ICH guidelines.