DOI: 10.21276/sajp.2016.5.8.8

Pages: 359-362

The aim of the present study was to develop and validate a HPLC method for assaying fexofenadine hydrochloride(FEX) in powder preparations prepared from Allegra® 60 mg tablets. A chromatographic system comprising a YMC AM12S05-1506WT column, mobile phase of CH3CN:H2O:HClO4:NaClO4=500:500:1:5 (V/V/V/W), flow rate of 1 mL/min, and UV detector set at 220 nm was used. The retention time of FEX was approximately 6.6 min. A regression analysis revealed that the method was linear over the standard curve range from 0.2 to 80 µg/mL. Intra-day precision and accuracy ranged between 0.1 and 19.6% and between -34.0 and 1.0%, respectively. The accuracy value at 0.50 µg/mL was -13.6%, which was out of the range of -10% to 10%. Therefore, the lower limit of quantification was inferred to be 0.50 µg/mL. Inter-day precision and accuracy values between 0.5 and 80 µg/mL ranged within 10% and from -10% to 10%, respectively, which were acceptable. The lower limit of quantification was established to be 0.50 µg/mL from validation data. The content of Allegra® 60 mg tablets was 100.60 ± 0.40% (mean ± SD, n=3). The method developed herein is useful for evaluating grinding tablets on dispensing when Allegra® 60 mg tablets are used as a model preparation.