Nantana NuchtavornJiraporn LeanpolchareanchaiDuangjai ChantonPatcharin SupapsophonSumet ChongruchirojJidapa ChatmapanrangseeJiraphong SuksiriworapongRamathibodi HospitalMahidol University2022-08-042022-08-042021-11-01Pharmaceutical Chemistry Journal. Vol.55, No.8 (2021), 845-854157390310091150X2-s2.0-85120160931https://repository.li.mahidol.ac.th/handle/20.500.14594/78937Quetiapine 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.Mahidol UniversityPharmacology, Toxicology and PharmaceuticsArticleSCOPUS10.1007/s11094-021-02505-x