Quantitative Analysis of Levocetirizine Dihydrochloride and Montelukast Sodium in Tablets by High Performance Thin Layer Chromatography with Ultra Violet Absorption Densitometry

A new simple high performance thin llayer chromatographic method for simultaneous determina ation of levocetirizine dihydrochloride and montelukast sodium m in bulk and tablet dosage form was investigated. Chromat tographic separation of the drugs were performed on aluminum m plates precoated with silica gel 60 F₂₅₄ as the stationary phase and the solvent system consisted of acetone:methanol:tol luene (2:2:6 v/v/v). Densitometric evaluation of the separated d zones was performed at 240 nm and the method was validated. The R_f values and drug content of levocetirizine dihydrochlloride and montelukast sodium were 0.18±0.02, 0.58±0.02 an nd 100.1%, 99.8% respectively. The calibration curves of peak area versus concentration, which were linear from 50–300 ng per band for levocetirizine dihydrochloride and 100–600 ng per band for montelukast sodium, regression coefficie ent (r²) was greater than 0.99. The method was validated f for linearity, accuracy, robustness and application for assay as per ICH guidelines. The study shows that the developed method is simple and accurate and it would be suitable for th he simultaneous determination of levocetirizine dihydrochlooride and montelukast sodium in bulk and pharmaceutical formu ulations.