Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS AND UNIFORMITY CONTENT OF FLUNARIZINE HYDROCHLORIDE IN TABLET PREPARATIONS

Fitra Yelli, Henny Lucida and Harrizul Rivai*

ABSTRACT

Flunarizine dihydrochloride is an antivertigo, anti-migraine, and adjunctive therapy in epilepsy and available commercially in Indonesia in the tablet dosage form. The monograph that exists in standard literature is in the form of the capsule dosage form. This study aims to develop an analytical method of flunarizine dihydrochloride in tablets including an assay and content uniformity. Development of the assay and content uniformity has been done by High-Performance Liquid Chromatography (HPLC) with a slight modification of the method from Pharmacopoeia of The People's Republic of China (2010) for capsules. The development of methods for the assay and content uniformity of flunarizine dihydrochloride in tablets was successfully done by HPLC using C18 5 μm (4.6x150) mm column, mixture methanol, and phosphate buffer - triethylamine pH 3.5 at a ratio of (75:25) as the mobile phase at a flow rate of 1 mL/min using UV detector at 253 nm. Validation of the assay of flunarizine dihydrochloride tablets indicates that the method meets the requirements for accepting a valid, accurate, and specific method so that it can be proposed as a routine testing procedure for monitoring the flunarizine dihydrochloride tablets sold in the Indonesian market.

Keywords: HPLC, flunarizine dihydrochloride, uniformity test, tablet.