Simultaneous Determination Of Phenylepherine Hydrochloride And Cetirizine Hydrochloride In Pharmaceutical Dosage Form

Abstract

RP-HPLC method have been developed and validated for simultaneous estimation of Phenylephrine hydrochloride and Cetirizine hydrochloride in bulk and pharmaceutical formulation. The RP-HPLC method for Phenylephrine hydrochloride and Cetirizine hydrochloride was developed with Ketotifen Fumarate as an Internal Standard using GraceSmart C18 column (250 mm × 4.6 mm, 5 m) as stationary phase and Acetonitrile:10mM Sodium Phosphate Dibasic Anhydrous buffer solution (40:60 % v/v, pH 6.2) as mobile phase. Mobile phase was maintained at a flow rate of 1.5 ml/min and detection was carried out at 220 nm. The amount of Phenylephrine and Cetirizine in marketed formulation by RP-HPLC methods was found to be in the range of 99.46 – 99.95 % and 99.24 – 100.84 %, respectively. Retention time was found to be 1.437 min, 2.373 min and 6.690 min for Ketotifen Fumarate, Phenylephrine hydrochloride and Cetirizine hydrochloride respectively. Results of assay and validation study were found to be satisfactory. The developed methods were statistically compared using One Way ANOVA with the help of Tukey-Kramer Multiple Comparison Test which suggested that there is no significant difference among the results of all the developed methods for both the drugs. So, the methods can be successfully applied for the routine analysis of Phenylephrine and Cetirizine in pharmaceutical formulation.