DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR METHYL GALLATE

Dr. Sushama Fulmali*, Dr. Ashish Jain and Dr. Pratima Tatke

ABSTRACT

An isocratic stability indicating RP-HPLC method was developed and validated for the assay of methyl gallate (MG). The marker and other degradation components were separated on a Thermo Hypersil BDS-C18 (250 x 4.6 mm, 5.0 μ) column. The mobile phase composed of water acidified with o-phosphoric acid (0.01%): acetonitrile (88:12 v/v). The mobile phase flow rate was optimized at 1.0 mL/min. The detection wavelength was selected as 271 nm. The method was linear over the concentration range of 5–50.0 μg/mL. Forced degradation studies of MG were carried out under conditions of acid, base and oxidative hydrolysis, sun light irradiation and in water to detect the major degradation products of the MG. The MG was found to be stable under acidic, neutral and in sun light irradiation. The alkaline conditions resulted in higher degradation of MG than oxidative conditions.

Keywords: Methyl gallate (MG), HPLC, stability indicating, forced degradation.