Original Article

Development and Validation of a New HPLC Method for the Determination of Quetiapine and Its Metabolites 7- Hydroxy Quetiapine and Quetiapine Sulfoxide in Rat Plasma

  • Işıl Tan YILMAZ
  • Erol ŞENER

Received Date: 09.07.2015 Accepted Date: 27.08.2015 Turk J Pharm Sci 2016;13(1):17-26

A new high performance liquid chromatography method was developed and validated for the determination of quetiapine and its metabolites 7-hydroxy quetiapine and quetiapine sulfoxide in rat plasma. Separation was per-formed on a C18 column (Zorbax Eclipse Plus 4.6 mm x100 mm, 3.5 μm particles) using a gradient elution at a flow rate of 1 mL/min. Mobile phase consisted of acetate buffer (10 mM, pH5) and acetonitrile. Analytes were detected with a DAD detector at 225 nm. Carbamazepine was used as internal standard in all analyses. Plasma samples were analyzed after a simple, one-step protein precipitation with acetonitrile. Separation time was 15 min including clean-up step. The method was validated in terms of precision, accuracy, recoveries, matrix effect and stability. It was found to be linearin the range of 0.065-130 μg/mL for quetiapine, 0.086-171 μg/mL for 7-hydroxy quetiapine and 0.042-83.35 μg/mL for quetiapine sulfoxide. All validation parameters were acceptable. This method was suc-cessfully applied to quantify the concentrations of the analytes in rat plasma.

Keywords: Quetiapine, 7-Hydroxy Quetiapine, Quetiapine Sulfoxide, HPLC, Rat plasma