DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF PHENYLEPHERINE HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE IN TABLET DOSAGE FORM

A simple, economical, specific, accurate, precise and validated Reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for simultaneous estimation of Phenylepherine hydrochloride (PPEH) and Cetirizine hydrochloride (CETH) in combine dosage form. The chromatographic separation was achieved on Princeton SPHER C18 column (250 mm x 4.6 mm id, 5 μ particle size) at ambient temperature using mobile phase buffer (0.1 M Ammonium dihydrogen phosphate pH 5.2 ± 0.05) : Acetonitrile (50:50% v/v) at flow rate 1.0 ml/min. Quantification was achieved with UV detector at 225 nm. Retention time of Phenylepherine hydrochloride and Cetirizine hydrochloride were found to be 2.19 ± 0.05 minute and 4.16 ± 0.05 minute respectively. Linearity was studied in the concentration range 5-30 μg/ml and 10-60 μg/ml for Cetirizine hydrochloride and Phenylepherine hydrochloride respectively with a correlation coefficient of 0.9998 and 0.9998 respectively. The proposed method was validated according to ICH guidelines with respect to linearity, accuracy, precision, robustness, LOD, and LOQ. The developed method with good separation, successfully applied for determination of PPEH and CETH in its pharmaceutical dosage form.