RP-HPLC Method Development and Validation for Quantification of Fexofenadine in Pharmaceutical Products

Abstract

Fexofenadine belongs to the antihistamine family of drugs. It is used to treat seasonal allergic rhinitis symptoms. In this study, a rapid, simple and sensitive liquid chromatographic method for the quantitative determination of fexofenadine was optimized and validated. Agilent Extend C18 column was used to perform the separation. The optimum chromatographic separation was achieved by the mobile phase consist of acetonitrile and 20 mM KH2PO4 solution (pH 7.5) in 35:65 ratios respectively. The flow rate of 1.2 mL min-1 with a standard retention time of 3.5 min at a wavelength 220 nm was optimized. The developed method has been validated in terms of their linearity, specificity, precision, accuracy, limits of detection and quantification, and robustness as per I.C.H. guidelines. The developed method has shown excellent linearity, precision, and recovery. There were no spectral or chromatographic interferences from non-medicinal ingredients found. Within a concentration range of 10–60 g mL-1, the correlation coefficient was greater than 0.999. Low relative standard deviation values were obtained in the results of intra-day and inter-day precision tests. The method's accuracy ranged from 99.45 to 100.52 %. The present analytical method can be used to quantify fexofenadine in pharmaceutical preparations.