Abstract

To develop and validate a simple, rapid, accurate and precise RP-HPLC method for the simultaneous determination of Pseudoephedrine sulphate (PSE) and Desloratadine hydrochloride (DES) in pharmaceutical formulation. The chromatographic separation was achieved on Zorbex Eclipse XDB C18, (250 x 4.6 mm, 5 μm). The mobile phase contains a mixture of Phosphate Buffer and Acetonitrile in the ratio of 60:40 (%v/v) and it was investigated to separate the drugs from their stressed degradation products. The flow rate was 1 ml/min, injection volume of 20 μL, run time of 15 minutes, at column oven temp 30°C. The detector wavelength was 220 nm. PSE and DES were subjected to stress degradation conditions of hydrolysis (acid and base), oxidation and thermal degradation. Stressed samples were analyzed by the developed procedures. The described method shows excellent linearity over a range of 72 to 720 μg/ml and 2 to 20 μg/ml PSE and DES, respectively. Degradation of PSE was observed in alkaline condition but found to be stable in other stress conditions while DES degradation was observed in oxidative conditions and found to be stable in other stress conditions. The proposed method was validated in terms of accuracy, precision, linearity, limit of detection and limit of quantification. Furthermore, no interference was observed with excipients in tablet for routine quality control analysis of PSE and DES in pharmaceutical formulations. This method is capable of complete chromatographic separation of PSE and DES peaks.