Development and Validation of RP-HPLC Method for the Quantitative Determination of Fexofenadine Hydrochloride in Tablet Dosage form

P. Rajamathi¹, A. Chenthilnathan^1* and A. Sathish babu^2
1Department of Pharmaceutical Chemistry, Manonmaniam Sundaranar University, Tirunelveli–627 012, Tamil Nadu, India.
²The Madras Pharmaceuticals, Chennai – 600 096, Tamil Nadu, India.

Abstract
Fexofenadine hydrochloride is a non-sedative and selective peripheral H1 receptor antagonist used for allergic rhinitis and chronic urticaria. This paper deals with a simple, feasible and sensitive reverse-phase high-performance liquid chromatographic method for the quantitative determination of fexofenadine hydrochloride in bulk drug and in pharmaceutical dosage forms. The chromatography was carried out by using HPLC system (Shimadzu LC2010HT) with UV- Visible dual absorbance detector (PDA), Inertsil 250 x 4.6 mm 5-μm packing L11 column. The mobile phase consisting of Acetonitrile and Buffer in the ratio of (9:16) [pH 5.25 adjusted with ortho phosphoric acid], detection was made at 220 nm and the mobile phase flowed at 2 ml min−1. Validation parameters included system suitability, specificity, linearity, accuracy and precision (repeatability & reproducibility) over a linearity range 50–150 μg/ml according to the ICH guidelines (r > 0.9999). The retention time of fexofenadine hydrochloride was 3.45 min. Hence, the method could be successfully applied for routine analysis of fexofenadine hydrochloride in pharmaceutical dosage forms.
Keywords: Fexofenadine hydrochloride, Solid dosage form, RP-HPLC, Validation.