Validated HPLC and Thin Layer-Densitometric Methods for Determination of Quetiapine Fumarate in Presence of its Related Compounds

Abstract

Two chromatographic methods were developed for determination of quetiapine fumarate in presence of three related compounds; namely quetiapine N-oxide, des-ethanol quetiapine and quetiapine lactam, in pure form and pharmaceutical preparation. The first method depended on densitometric thin layer chromatography where the separation was achieved using silica gel 60F(254) plates as stationary phase and toluene:1,4-dioxane:dimethylamine (5:8:2, v/v/v) as a mobile phase. The second method utilized the reverse phase high performance liquid chromatographic technique, using C18 column and methanol: acetonitrile: phosphate buffer (pH 5.3) in a ratio (19:40:41, v/v/v) as a mobile phase. The flow rate was1 mL min-1 and UV-detection was at wavelength 220 nm. The validation parameters of the developed methods were calculated and the results obtained were statistically compared with those of the HPLC manufacturer method.