Analysis of second-generation anti histamine fexofenadine soft gelatin capsules and its related compound by using RP-HPLC

A simple, novel, sensitive, fast high-performance liquid chromatographic (RP-HPLC) method has been
developed and validated for the quantitative determination of fexofenadine HCl and its related (compound
A) in bulk and formulations. The drug was degraded by oxidation, acidity, basicity, neutrality, photolysis,
and heat. In a total analytical run time, all degradation products were eluted. The chromatographic
development was carried out on RP-HPLC. The column used as zorbax SB phenyl, L11, 250 mm x 4.6 mm
x 5 mm column or equivalent with mobile phase consisting of acetonitrile 700 ml, 300 ml of buffer and 6
ml of triethylamine. The particles were seen at 220 nm and the flow rate was 1.5 ml/min. The retention
time was found to be 8.415 min for fexofenadine and its related (compound A) is 13.961 min. In terms of
linearity, accuracy, precision, and robustness, the technique was verified in accordance with the ICH Q2 R1
guidelines. With a regression value of 0.999, the calibration curve was discovered to be linear throughout
a range of 45.2867-135.8601 µg/ml. The technique has demonstrated good specificity and sensitivity.
The results of the research demonstrated the utility of the suggested RP-HPLC technique for the routine
detection of fexofenadine in bulk medication and in its pharmaceutical formulation