Abstract

A CHROMATOGRAPHIC METHOD FOR THE ANALYSIS OF GLICLAZIDE IN BULK AND TABLET DOSAGE FORMS

Venkataramana N. V., Krishnaswamy G., Nivedita R. Desai, Chaluvaraju K. C., Aruna Kumar D. B.*

ABSTRACT

A straightforward, selective, linear, precise, accurate and robust reverse phase high performance liquid chromatography method was designed and validated for the rapid assay of gliclazide in bulk and pharmaceutical tablet dosage form and their degradation studies such as acid hydrolysis, alkali hydrolysis and peroxide stressed were carried out. Isocratic elution at a flow rate of 1.2 ml min-1 was employed using symmetry Luna C8 column(250mm×4.6mm,3μ),Column at a temperature of 400C.The mobile phase used consisted of phosphate buffer: tetrahydrofuran (A) (70:30) and acetonitrile (B) (100%) in the ratio of 50:50 v/v. The chromatograms were recorded at a wavelength of 230 nm using UV-detector. Linearity was observed in the concentration range of 25-125 μg/ml. The retention time of gliclazide was found to be 6.4 min. The method was validated as per the international conference on harmonization (ICH) guide lines and the designed method can be successfully applied for the estimation of gliclazide in pharmaceutical formulations.

Keywords: chromatography, Tablet, gliclazide, analysis, acetonitrile, tetrahydrofuran.