Abstract

DEVELOPMENT OF NEW ANALYTICAL METHODS FOR THE ESTIMATION OF FLUPIRTINE MALEATE IN BULK AND IN FORMULATIONS

M.Ramakrishna, Venkata S Rao Somisetty, Dr.P.Rambabu,Dr. A.M.S. Sudhakarbabu, Dr.M.V. Ramana

Abstract

Two simple, sensitive, specific UV - spectroscopic and RP-HPLCmethods are developed for the estimation of Flupirtine Maleate in bulkand pharmaceutical formulation. The first method was based on UV –spectroscopic determination of the drug. It involves absorbancemeasurements at 319nm (λ max of Flupirtine Maleate) inacetonitrile:water. Calibration curve was linear with the correlationcoefficient was 0.9999 over a concentration range of 2 to 35 μg/ml forthe drug. The second method was based on HPLC separation of thedrug in reverse phase mode using C18 column (150 mm × 4.6 mm i.d.5μ). The mobile phase constituted of Acetonitrile: water: Methanol(40:40:20 v/v) and flow rate 1.0ml/min. Detection was performed at 249nm. Separationcompleted with in 5minutes. Calibration curve was linear with the correlation coefficient was0.9998 over a concentration range of 5 to 30 μg/ml for the drug. The relative standarddeviation (R.S.D) was found <2.0% for UV – spectroscopic and RP-HPLC methods. Boththese methods have been successively applied to bulk and pharmaceutical formulation. Thepresent methods were validated according to ICH guidelines.

Keywords: Flupirtine Maleate, UV-spectroscopy, High performance liquid chromatography