Reversed Phase High Performance Liquid Chromatographic Method for Determination of Quetiapine Fumarate in Pharmaceutical Formulation and in Spiked Human Urine

摘要

A precise and feasible reversed-phase high-performance liquid chromatographic method for the determination of an antipsychotic drug quetiapine fumarate (QTF) in pharmaceuticals and spiked human urine sample has been developed and validated. The analysis was carried out using a ODS (250 mm × 4.6 mm i.d., 5 μm particle size) chromatopack column. Mobile phase containing a mixture of acetonitrile and 0.1% phosphate buffer (pH 3.1) (40:60) was pumped at a flow rate of 1 mL/min with UV detection at 240 nm at ambient column temperature (25 oC). The method showed good linearity in the range of 0.09 – 18 μg/mL QTF with limits of detection (LOD) and quantification (LOQ) values of 0.03 and 0.09 μg/mL, respectively. The suggested method was successfully applied for the analysis of QTF in bulk drug, tablets and human urine with average recoveries of 100.06, 100.26 and 98.83%, respectively. The intra- and inter-day RSD values were less than 5%. The method is accurate, precise, sensitive and selective for routine analysis in quality control laboratories.