Quality control of commercial tablets containing the novel antipsychotic quetiapine.

Quetiapine (bis [2-(2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)ethoxy)ethanol]fumarate) is the most recent agent introduced on the drug market for the treatment of psychotic disorders. Two different analytical methods for the quality control of quetiapine in commercial formulations have been developed and compared: a spectrophotometric method and a capillary zone electrophoretic (CZE) method. The spectrophotometric assay was carried out measuring the absorbance at a wavelength of 246 nm. The CZE method used an uncoated fused-silica capillary and a pH 2.5, 50 mM phosphate buffer as the background electrolyte. The detection wavelength was 205 nm, the separation voltage was 15 kV, and a complete electrophoretic run lasts less than 2.5 min. Extraction of quetiapine from the commercial tablets consisted of a simple one-step treatment with a pH 2.5, 50 mM phosphate buffer. Linearity was observed in the 5-25 mug ml(-1) concentration range of quetiapine for the spectrophotometric method, and in the 5-50 mug ml(-1) concentration range for the electrophoretic method. Both methods gave satisfactory results in terms of repeatability and intermediate precision (RSD < 1.9%). Also accuracy values were very good for both methods, the recovery being between 98.2 and 100.5%.