Objective: A simple and accurate stability indicating reversed-phase high-performance liquid chromatography method was developed and validated for the simultaneous estimation of phenylephrine and fexofenadine in pharmaceutical dosage forms.Methods: Chromatography was carried out on an Kromasil C-18 column (4.6 mm×250 mm, 5 µ particle size) with a isocratic mobile phase composed of ortho phosphoric acid buffer, acetonitrile, (75:25% v/v) at a flow rate of 1 mL/minutes. The column temperature was maintained at 30°C and the detection was carried out using a photodiode array detector at 210 nm. Results:The retention times for phenylephrine and fexofenadine were 2.156 minutes and 3.359 minutes, respectively. The percentage recoveries of phenylephrine and fexofenadine were 100.63% and 99.84%, respectively. The relative standard deviation for assay of tablets was found to be <2%. The detection and quantification limits were found to be 0.10 and 0.31 µg/mL for phenylephrine and 0.01 and 0.03 µg/mL for fexofenadine, respectively. Conclusion:Thus, the method was fast, accurate, precise, and sensitive; hence, it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries.

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