Abstract
A simple and rapid isocratic HPLC-UV method for the routine quality control of fexofenadine hydrochloride in synthesis products has been established. By using triethylamine-phosphoric acid aqueous solution (0.10 mol/L) /methanol (45:55) mobile phase (flow rate 1.0 mL/min) and ODS column at ambient temperature, fexofenadine hydrochloride can be well separated from its 3 major synthetic intermediate impurities in 15 minutes. The representative linear equation of the method was Y=1.103x10^3x-1.186x10^3, where X is the concentration of fexofenadine hydrochloride and Y is the peak area, with correlation coefficient (R) of 0.9999 (n=3). The limit of quantitation (LOQ) and limit of detection (LOD) of the proposed method were 180 ng and 60 ng, respectively. The RSD of intra- and inter-day precision test of the method were 0.43% and 0.28%, respectively, which had shown great promise in the quality control routine analysis of fexofenadine hydrochloride. The proposed method was demonstrated in degradation test of fexofenadine hydrochloride.
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