A Rapid Stability Indicating HPLC Method for Determination of Quetiapine Fumarate in Tablets and Extemporaneous Formulations

Abstract

Quetiapine fumarate is an atypical antipsychotic drug, which is clinically used for the treatment of depression and bipolar disorders. A stability indicating method is required for the quality control of pharmaceutical dosage forms. This work focused on the developments of a rapid stability indicating reversed-phase HPLC-UV method for determination of quetiapine fumarate in tablets and extemporaneous formulations. Quetiapine fumarate was simultaneously determined in the presence of three impurities: quetiapine related compound B, quetiapine related compound G, and quetiapine N-oxide within 9 min. Optimal HPLC conditions were realized using Zorbax C8 column (100 mm × 4.6 cm i.d., 3 μm particle). Gradient elution utilized mobile composition of 0.15% triethylamine (pH 6.0) and acetonitrile : methanol (80:20) mixture at a flow rate of 1.2 mL/min with detection wavelength at 252 nm. The proposed method showed good linearity (r2 > 0.998), precision (RSDs ≤ 2.2), and accuracy (%recovery 96.8 – 99.4, RSD ≤ 1.9) with acceptable limits of detection (LOD ≤ 3.0 μg/mL) and quantitation (LOQ ≤ 10 μg/mL) at RSD ≤ 2.8). The method was successfully applied to the determination of quetiapine fumarate in pharmaceutical formulations and stability testing of extemporaneous formulations.