Validation of stability indicating high performance liquid chromatographic method for estimation of Desloratadine in tablet formulation

Abstract

A simple, sensitive and specific stability indicating high performance liquid chromatographic (HPLC) method for the estimation of Desloratadine was developed and validated. Desloratadine was separated and quantitated on Inertsil ODS-3V column (250mm length, 4.6mm id, 5μm particle size) using a mixture of methanol–phosphate buffer of pH 7.0 (70:30 v/v) as a mobile phase and at a flow rate of 1.0mL/min. Quantification was achieved with an UV detector at 254nm over the concentration range of 5–75μg/mL. The applied HPLC method allowed the separation and quantification of Desloratadine with good linearity (r2=0.999) in the studied concentration range. Limit of detection and limit of quantification were found to be 1.28μg/mL and 3.89μg/mL, respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Desloratadine stock solution was subjected to different stress conditions. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed HPLC method. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Desloratadine. The method was successfully applied to the estimation of Desloratadine in tablet dosage form.