DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR GALLIC ACID

Fulmali SushmaV and Tatke Pratima A.*

ABSTRACT

An isocratic stability indicating RP-HPLC method was developed and validated for the assay of gallic acid (GA).The marker and other degradation components were separated on aThermo Hypersil BDS-C18 (250 x 4.6 mm, 5.0 μ) column. The mobile phase composed of water acidified with phosphoric acid (0.01%): methanol in a ratio 95:5.The mobile phase flow rate was optimized at 1.0 mL/min. The detection wavelength was selected as 271nm.The method was linear over the concentration range of 5–50.0 μg/mL. Forced degradation studies of GA 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 GA. The GA was found to be stable under acidic, neutral and in sun light irradiation. The alkaline conditions resulted in higher degradation of GA than oxidative conditions.

Keywords: Gallic acid, HPLC, stability indicating, forced degradation.