Comparative Study for Direct Evaluation of Montelukast Sodium in Tablet Dosage Form By Multiple Analytical Methodologies

Abstract

Different non-sophisticated analytical methods consisting of Ultraviolet Spectrometry (UV), Osteryoung Square Wave Voltammetry (OSWV) and flow injection analysis (FIA) were developed, validated according to ICH Q2 (R) 1 guideline and applied for the determination of Montelukast Sodium (MLS) in bulk and tablet formulation. In the UV absorbance spectrum, MLS exhibits more absorption maxima, the main ones being found at the wavelengths of 211.4 and 344.4 nm, respectively. The determination was performed at 344.4 nm. In OSWV determinations rely on the reduction of MLS at the hanging mercury electrode (HMDE). This reduction is mainly diffusion-controlled in Britton-Robinson buffer, a cathodic peak appearing at pH 4.0 in 0.15 M LiCl solutions containing also 40% methanol. In FIA determinations, the carrier solvent was 50% methanol at 1mL/min flow rate. The FIA connected to UV detector. The calibration graphs obtained for the three analytical methods applied in determinations were rectilinear over the ranges of 0.9989, 09976 and 0.9997 for UV, OSWV and FIA respectively. The statistical comparison of the obtained results demonstrates that the three developed methods are very similar in respect of both accuracy and precision.