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Development and Validation of Stability Indicating UPLC Method for Simultaneous Estimation of Phenylephrine and Fexofenadine in Suspension Dosage Form

Phenylephrine and fexofenadine are widely used products for common cold and allergic conditions. In this study, a simple, reliable, sensitive and economical Ultra Performance Liquid Chromatographic (UPLC) method was developed and validated for the simultaneous estimation of phenylephrine and fexofenadine in suspension dosage form. Efficient chromatographic separation was achieved on Acquity UPLC HSS C18 x 1.8μm column with mobile phase consisting of orthophosphoric acid buffer (pH = 2.8) and acetonitrile (55:45% v/v) at a flow rate of 0.3ml.min-1 and 1μl injection volume. TUV detector was used and detection wavelength was 272nm. The retention times of phenylephrine and fexofenadine were found to be 1.347 and 1.536 ± 0.01 mins respectively. The percentage recoveries of phenylephrine and fexofenadine were 99.93% and 99.31% respectively. The relative standard deviation for assay was found to be <2. The detection and quantification limits were found to be 0.04 and 0.13μg/ml for phenylephrine and 0.21 and 0.65μg/ml for fexofenadine respectively. Thus, the developed UPLC method was simple, rapid, sensitive and economical and it can be applied for the routine quality control analysis of combined dosage forms in quality control laboratories and in pharmaceutical industries.