Abstract

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

Ch.Vijayalakshmi, Dr. N. Srinivasu, Dr. D. Ramachandran*and K. Geetha Bhavani

ABSTRACT

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Resiperidone in tablet formulations. The separation was achieved by using column Hypersil BDS C18, 150x4.6 mm, 5μ (Make: Thermo), in mobile phase consisted of methanol and ammonium acetate buffer pH adjusted to pH 6.2 with the help of dilute glacial acetic acid in the ratio of (50:50, v/v). The flow rate was 1.5 mL. min-1 and the separated Resiperidone was detected using UV detector at the wavelength of 275 nm. The retention time of Resiperidone, was noted to be 5.25 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; Resiperidone, Validation.