Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF RUFINAMIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

Apexa Patel, Dr B.N Suhagia, Arpit Patwari

Abstract

ABSTRACT A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the determination of Rufinamide, using C18 column and a mobile phase composed of acetonitrile: water (60:40 v/v), pH 7.0. The retention time of Rufinamide was found to be 3.043 min. Linearity was established for Rufinamide in the range of 10-80 μg/mL. The percentage recovery of Rufinamide was found to be in the range of 97.15-100.6 %. The drug was subjected to acid, alkali, oxidation, dry heat and Photolytic degradation. The degradation studies indicated condition was well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for quantitative analysis of Rufinamide in bulk drug and formulation.

Keywords: Rufinamide, Stability indicating method, HPLC.