Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PROPRANOLOL HYDROCHLORIDE AND FLUNARIZINE DIHYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Pranali V. Joshi* and Teja V. Walke

Abstract

The present study deals with development and validation of an accurate, specific and precise UV spectrophotometric method with greater sensitivity and reproducibility for the simultaneous estimation of Propranolol hydrochloride and Flunarizine dihydrochloride in pharmaceutical dosage form by Vierdot’s method using 0.1N HCL as a solvent. The method involves measurement of absorbance at λmax of Propranolol hydrochloride and Flunarizine dihydrochloride at 291nm and 253nm respectively. The developed method was found to show linearity in concentration range of 10-100μg/ml and 2.5-25 μg/ml for Propranolol hydrochloride and Flunarizine dihydrochloride respectively. % recovery of Propranolol hydrochloride and Flunarizine dihydrochloride was found to be 100.5% and 100.0% respectively. The % relative standard deviation showed during inter and intraday precision studies were also found to be within limits of NMT 2%. Validation of this method is done as per ICH Q2(R1) guideline.[1] The developed method can be used for routine analysis of Propranolol hydrochloride and Flunarizine dihydrochloride in tablet formulation.

Keywords: Propranolol hydrochloride, Flunarizine dihydrochloride, UV spectrophotometry, Validation.