FORCED DEGRADATION STUDIES OF COMBINATION OF LEVOCETRIZINE, AMBROXOL AND MONTELEUKAST BY VALIDATED RP-HPLC METHOD

A new selective rapid reverse phase high performance liquid chromatographic stability indicating method had been developed and validated for simultaneous quantitative determination of Levocetrizine, Ambroxol and monteleukast in bulk and pharmaceutical dosage form. The chromatographic separations are carried out with Kromasil C-18, (250×4.6 mm) and 5μm particle size column. The mobile phase consists of phosphate buffer: Acetonitrile (40:60 %v/v), to this add 1 ml of triethylamine and adjust the mobile phase pH 4.0 with o-phosphoric acid. The flow rate was 1.0 mL/min and eluents were detected at 225 nm using UV detector. The retention times of Levocetrizine, Ambroxol and Monteleukast were found to be 2.185, 2.622 and 3.931 min respectively. The percentage recoveries were found to be in the range of 99 -101%. The calibration curve was constructed between peak area vs concentration and demonstrated which are in the range of 500μg/ml Levocetrizine, 50 μg/ml Ambroxol and 100 μg/ml Monteleukast. Degradation studies were studied for Levocetrizine, Ambroxol and monteleukast under various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, thermal, photochemical and UV. All the degradation peaks were resolved effectively using developed method with different retention times. The developed method was validated according to ICH guidelines. As the method could effectively separates the degradation products from active ingredient, it can be used for routine analysis of drug both in bulk and pharmaceutical dosage form.