Quetiapine hemi fumarate and Validation

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Fumaric acid in Quetiapine hemi fumarate drug substance. The separation was achieved by using column Hypersil C18 (250×4.6mm, 5µm), in mobile phase consisted of acetonitrile and pH 3.0 phosphate buffer, adjusted to pH 3.0 with the help of dilute orthophosphoric acid in the gradient elution. The flow rate was 1.0 mL/min-1 and the separated Fumaric acid was detected using UV detector at the wavelength of 210 nm. Column temperature 25°C and sample temperature ambient and injection volume 20µl. The retention time of Fumaric acid, was noted to be 3.65 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.