Abstract

Abstract

The present study focuses on the development and validation of a simple, precise, and reliable analytical method for the estimation of fexofenadine hydrochloride combination with phenylephrine hydrochloride (API) and liquid dosage form using reverse phase high-performance liquid chromatography (RP-HPLC). The primary objective of this work was to establish an efficient chromatographic method suitable for routine quality control analysis. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of methanol, Ammonium acetate buffer in gradient elution. The analysis was carried out at a detection wavelength of 220nm. The optimized conditions provided a well-defined chromatogram with good peak shape and resolution for fexofenadine & phenylephrine. The developed method was validated according to ICH guidelines, demonstrating acceptable levels of accuracy, precision, linearity, and specificity. The method showed consistent and reproducible results for the quantification of fexofenadine hydrochloride combination with phenylephrine hydrochloride (API) and suspension formulation.

Keywords: Fexofenadine Hydrochloride, Phenylephrine Hydrochloride, Hplc, Method Development, Validation.