METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PROPRANOLOL HYDROCHLORIDE AND FLUNARIZINE DIHYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Abstract

A simple, efficient, reproducible RP-HPLC method for the simultaneous determination of Propranolol hydrochloride and Flunarizine dihydrochloride in bulk and pharmaceutical dosage form has been developed and validated. The seperation was carried out on Agilent xdb C18 (150mm4.6mm I.D; particle size 5m) column with a mobile phase consisting of methanol, acetonitrile and potassium dihydrogen phosphate (adjusted to pH 3.0 using orthophosphoric acid) in the ratio 20:20:60 respectively at a flow rate of 1.0 mL/min. Detection was carried out at 264nm. The retention times of Propranolol hydrochloride and Flunarizine dihydrochloride were found to be 2.058min and 6.708min respectively. The described method was linear over a concentration range of 10-60µg/mL and 5-30µg/mL. The proposed method was validated as per ICH guidelines. The developed method has adequate sensitivity, reproducibility and specificity for determination of Propranolol hydrochloride and Flunarizine dihydrochloride in bulk and its tablet dosage forms.