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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-HPLC
methods are developed for the estimation of Flupirtine Maleate in bulk
and pharmaceutical formulation. The first method was based on UV –
spectroscopic determination of the drug. It involves absorbance
measurements at 319nm (λ max of Flupirtine Maleate) in
acetonitrile:water. Calibration curve was linear with the correlation
coefficient was 0.9999 over a concentration range of 2 to 35 μg/ml for
the drug. The second method was based on HPLC separation of the
drug 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. Separation
completed with in 5minutes. Calibration curve was linear with the correlation coefficient was
0.9998 over a concentration range of 5 to 30 μg/ml for the drug. The relative standard
deviation (R.S.D) was found <2.0% for UV – spectroscopic and RP-HPLC methods. Both
these methods have been successively applied to bulk and pharmaceutical formulation. The
present methods were validated according to ICH guidelines.

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


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