Abstract

DEVELOPMENT AND VALIDATION OF RP-LC METHOD FOR METAXALONE IN PHARMACEUTICAL FORMULATIONS

Venkateswara Reddy Billa*, Prof. Anuradha Vejendla, Prof. Ramachandran Dittakavi and Naveen Reddy Seelam

Abstract

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Metaxalone in tablet formulations. The separation was achieved by using column Waters Acquity HSS T-3 C18 (100 × 2.1 mm, 1.7μm) in mobile phase consisted of pH 4.0 phosphate buffer and methanol in the ratio of (60:40, v/v). The flow rate was 0.8 mL/min-1 and the separated Metaxalone was detected using UV detector at the wavelength of 228 nm. Column temperature 25°C and sample temperature ambient and injection volume 10μl. The retention time of Metaxalone, was noted to be 7.05 min respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible and consistent.

Keywords: Liquid Chromatography, Metaxalone, Validation.