STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FEXOFENADINE HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

A simple, rapid and accurate method was developed for the determination of Fexofenadine Hydrochloride in bulk and pharmaceutical dosage form by RP-HPLC method using C₁₈ column [4.6×250mm,5μm] in binary gradient mode.  The mobile phase consisted of methanol and water in the ratio of 80:20 v/v. The flow rate was maintained at 1.2 mL/min and wavelength was maintained at 220 nm. The column oven temperature was maintained at 40°c. The retention time of Fexofenadine Hydrochloride was attained at 2.96 min. The method was linear over the concentration range from 7.5-40μg/mL and R² was found to be 0.999. The intraday and interday precision %RSD values were obtained <2.0. The LOD and LOQ were attained at 0.603 and 1.829μg/mL respectively. The accuracy results of the method was obtained 98.37-99.84% at different levels of concentrations. The method was proved as robust after deliberately changed parameters of flow rate, mobile phase composition, temperature and wavelength. The method was shown ability to words different stress conditions of acid, base, peroxide and UV-Light. The method was used for routine analysis of Fexofenadine hydrochloride in pharmaceutical dosage form.

Key Words: Fexofenadine hydrochloride, RP-HPLC, Methanol, Stability studies.