Development and Validation of Chemometric Assisted Fourier Transform Infrared Spectroscopic Method for Simultaneous Determination of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Dosage Forms

Abstract

A new analytical method has been developed for the simultaneous estimation of Montelukast sodium and Fexofenadine hydrochloride in pharmaceutical dosage forms using chemometrically assisted Fourier Transform Infrared (FTIR) Spectroscopy. This method involves preparation of solid pellets of Montelukast sodium and Fexofenadine hydrochloride using Potassium bromide (KBr) with the aid of geometric mixing. The spectra were measured by direct measurement technique using reduced path length in absorbance mode and the equipment was configured to collect spectra at 8cm-1 resolution. The spectra were collected between the ranges of 4000cm-1 to 450cm-1. Infrared spectra of the two drugs showed different functional group peaks with base line correction; from which intense, clear and proportionate peaks at 1704cm-1 and 3421cm-1 corresponding to C=O stretching and O- H group were selected for Montelukast and Fexofenadine respectively for quantitative estimation using chemometrics. Beer-Lambert’s law was obeyed over the concentration range of 5-25 μg/mg for Montelukast and Fexofenadine. The developed method was validated according to International Conference on Harmonisation (ICH) guidelines. The validation parameters - precision, accuracy, limit of quantitation, limit of detection were determined and found to be within the limits. This method was successfully applied for analysis of marketed formulations of Montelukast sodium and Fexofenadine hydrochloride.