Analytical Method Development and Validation of Desloratadine Tablet

Abstract

The present work involves the Development and validation of RP-HPLC method for estimation of Desloratadine in tablet dosage form. Desloratadine is a tricyclic anti histamine, which has a selective and peripheral H1 antagonist action. It is used to treat allergies. The developed method is simple, specific, accurate and precise. The separation was achieved using Phenomenex C18 (250mm X 4.6mm), 5μm column and Methanol: Water (70:30, v/v) as mobile phase with flow rate 1.0 ml/min. Detection was carried out at 242 nm. The retention time of Desloratadine was found to be 5.79. The linearity and range was found to be 8–24 μg/ml. The co-relation coefficient was found to be 0.9975. The % recovery of Desloratadine was found to be 98.29 to 99.37. The method was precise as % RSD for repeatability, intraday precision and interday precision was found to be 0.56, 0.50 to 1.03 and 0.15 to 0.64 respectively. The %RSD for robustness was found to be 0.33 to 1.13 during variation in flow rate and 0.73 to 1.02 during variation in wavelength which confirms that the method was robust. The method can be successfully employed for estimation of Desloratadine in tablet dosage form as assay was found to be 99.40% to 102.00%. The developed method was simple, specific and economic.