Validation and Application of a Modified RP-HPLC Method for the Quantification of Desloratadine in Pharmaceutical Dosage Forms

Abstract

The purpose of the study was to develop a simple, sensitive and rapid RP-HPLC method for the determination of desloratadine in marketed products. Chromatographic determination was performed in a reverse phase C18 column (250 mm × 3.3 mm I.D. , 5?m particle size) using a mixture of acetonitrile ? n-pentane sulphonic acid sodium salt monohydrate, adjusted to pH 3.0± 0.05 with phosphoric acid (60? 40 v/v) as mobile phase and delivered at a flow rate of 1 ml/min. The UV detection was set at 254 nm. The calibration range was from 2.0 to 40 ?g/ml. The method was validated in term of linearity (r2>0.98, RSD= 1.958%), precision (RSD=3.757 %) and accuracy (deviation>2.653%, RSD> 2.203%). The limit of quantification was 2 ?g/ml and the limit of detection was 0.1 ?g/ml. The linear ranges of desloratadine were 20.23 ± 0.368 ?g/ml and 6.545 ± 0.0495 ?g/ml in tablet (potency = 99.175 ± 0.718 %) and syrup (potency = 101.15 ± 1.838 %) respectively. The potency of desloratadine in marketed products was determined by this method with acceptable precision and reproducibility.