STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR PSEUDOEPHEDRINE HYDROCHLORIDE AND FEXOFENADINE HYDROCHLORIDE IN TABLET DOSAGE FORM

High performance liquid chromatographic (HPLC) method was described for determination of Pseudoephedrine Hydrochloride (PSE) and Fexofenadine Hydrochloride (FEX). The chromatographic separation was achieved on Kinetex C₁₈, (250 x 4.6 mm i.d), Particle size 5µm. The mobile phase contains a mixture of 0.005 M Dioctyl Sodium Sulfosuccinate Buffer in a mixture of 50 volume of Methanol, 10 volume of Acetonitrile, 40 volume of Water and 1 volume of Glacial Acetic Acid was investigated to separate the drugs from their stressed degradation products. The flow rate was 1.2 ml/min, injection volume of 50 µL, run time of 15 minutes, at column oven temp 50°C. The detector wavelength was 258 nm. PSE and FEX 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 720μg/ml and 48 to 480μg/ml PSE and FEX, respectively. Degradation of PSE was observed in oxidative condition but found to be stable in other stress conditions while FEX degradation was observed in oxidative conditions and found to be stable in other stress conditions. This method is capable of complete chromatographic separation of PSE and FEX peaks