Stability Indicating RP-HPLC Method for the Estimation of Fexofenadine HCL in Bulk and its Tablet Dosage Form

摘要

Stability indicating RP-HPLC method was developed and validated for the quantitative determination of Fexofenadine in tablet dosage form. Separation was achieved using an Inertsil ODS-3V column with flow rate of 1.0ml/min using PDA detector and eluents are observed at 245 nm. The mobile phase consisting of 100% methanol. The drug was reacted with the oxidation, hydrolysis, photolysis and thermal degradation. The method was linear over the concentration range of 10-50μg/ml (r2=0.999) with detection and quantification limit of 0.1 μg/ml and 0.4 μg/ml respectively. The method was accurate, precise and robust for the assay of Fexofenadine in pharmaceutical dosage forms.