A reliable and sensitive stability indicating HPLC method has been developed and validated for montelukast sodium and desloratadine in its dosage form. A separation of montelukast sodium and desloratadine were achieved on ODS hypersil C18 (250 mm × 4.6 mm, 5 μ) column using a UV detector to monitor elute at 230 nm. The mobile phase consisted of 0.3% triflouroacetic acid with water: acetonitrile (20:80 v/v) and flow rate of 1.0 ml/min. The retention time were found to be 6.12 min and 4.19 min for MON and DES respectively. Rectilinear relationship with good regression coefficients 0.9969 and 0.9998 was found over the concentration ranges of 80-120 μg/ml and 40-60 μg/ml for MON and DES, respectively, with detection limits 11.51 µg/ml for montelukast sodium and 4.06 µg/ml for desloratadine and quantitation limits 34.89 µg/ml for montelukast sodium and 12.32 µg/ml for desloratadine. Inter day precision (%RSD) for MON and DES were 0.383-1.021 and 0.558-0.695 respectively. Accuracy was 99.55-100.20 for MON and 99.56-100.15 for DES. The drugs were subjected to hydrolysis, oxidation, photolysis and thermal degradation. Because the method could effectively separate the drug from its degradation products, it can be used for stability-indicating analysis.
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