Abstract

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

Anil Shahaji Khile, N. Gayatri Devi, M. Subba Rao and Dr. D. Ramachandran*

Abstract

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Armodafinil in tablet formulations. The separation was achieved by using column Delvosil ODS –UG-5 C18 (250×4.6 mm, 5μ), in mobile phase consisted of acetonitrile and pH 2.5 phosphate buffer, adjusted to pH 2.5 with the help of dilute orthophosphoric acid in the ratio of (60:40, v/v). The flow rate was 1.2 mL/min-1 and the separated Armodafinil was detected using UV detector at the wavelength of 220 nm. Column temperature 35°C and sample temperature ambient and injection volume 10μl. The retention time of Armodafinil, was noted to be 4.45 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; Armodafinil, Validation.