DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF QUETIAPINE FUMARATE FROM PHARMACEUTICAL PREPARATION
A simple, sensitive, rapid, robust and reproducible method for the determination of Quetiapine fumarate in bulk and pharmaceutical formulation (Tablets) was developed using reverse phase high performance liquid chromatographic method (RP-HPLC). The RP-HPLC analysis was performed isocratically on XTERRA C18 (4.6X150mm), analytical column using a mobile phase consisting of 2.5PH buffer and acetonitrile in the Ratio of 40:60v/v, with a flow rate of 0.8ml/min. The analyte was monitored with UV detector at 294nm. The developed method Quetiapine fumarate elutes at a retention time of 2.839 min. The proposed method is having linearity in the concentration range from10 to50 µg/mL of Quetiapine fumarate. The present method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery), ruggedness, and robustness. The proposed method can be readily utilized for bulk drug and pharmaceutical formulations.