Development and Validation of RP–HPLC Method For Simultaneous Estimation of Cetrizine Hydrochloride and Phenylephrine Hydrochloride in Bulk and Tablet Dosage Form

Cetrizine hydrochloride and Phenylephrine hydrochloride are used in combination in the treatment of allergy. The aim of this project work is to develop selective, accurate, specific and economic RP–HPLC method for simultaneous estimation of Cetrizine hydrochloride and Phenylephrine hydrochloride in Bulk and Tablet dosage form. The reverse phase C18 (250 mm × 4.6 mm i.d) column with 5 µm particle size was used. Acetonitrile: Water was taken as mobile phase was with a flow rate of 1 mL/min and detection was carried out at 222 nm. The retention time of Cetrizine hydrochloride and Phenylephrine hydrochloride was 1.956 min and 4.561 min respectively. The calibration curves were linear (>0.998) in the range of 5-25 μg/ml for Cetrizine hydrochloride and Phenylephrine hydrochloride. The Limit of Detection for Cetrizine hydrochloride and Phenylephrine hydrochloride was found to be 0.26 μg/mL and 0.51μg/mL. The Limit of Quantification was found to be 0.81μg/mL and 1.54 μg/mL respectively for Cetrizine hydrochloride and Phenylephrine hydrochloride. The developed method was simple, selective and precise and can be used for routine analysis of Cetrizine hydrochloride and Phenylephrine hydrochloride in tablet dosage form.