Method Development and Validation of Quetiapine Fumerate by Using RP-HPLC

A rapid, precise, and selective reverse-phase high-performance liquid chromatography (RP-HPLC) method was established and validated for the analysis of QTPF (QUETIAPINE FUMERATE) pure drug as well as commercial formulation. This RP-HPLC approach is designed for the regular determination of QTPF in both laboratory-prepared mixtures and combined pharmaceutical formulations. The separation process utilized an INERTSIL C-18 ODS column (physical dimension 250×4.6mm, 5µm particle size), employing a mobile phase of methanol and ammonium acetate (30 Mm) in a 95:5 ratio, with a flow rate of 1ml/min. The detection of QTPF was achieved using UV spectrophotometry method. QTPF was found to be highly soluble in ACN and methanol in ratio of 70:30, and its wavelength was found to be 252nm. Retention time of QTPF was found to be 3.4 min. The LOD and LOQ values were found to be 0.0001 (µg/ml) and 0.0003, (µg/ml) respectively. In the linearity curve of 2 to 64(µg/ml) of sample, correlation coefficient R2 is seen to be 0.9992. The system suitability parameters such as theoretical plates and tailing factor were found to be 1.99 and 1.30, respectively, and RSD was found to be 1.45.