HPLC and spectrophotometric determination and formulation of quetiapine fumarate in the pharmaceutical dosage forms

Abstract

The aim of this work was to develop and validate of assay and dissolution tests for quetiapine fumarate in the pharmaceutical dosage by using HPLC and spectrophotometric analyses. The assay method with HPLC analysis was found to be linear in the concentration range of 80 to 200 μg/mL. The validation included linearity, accuracy and precision. In addition, drug stability in medium was demonstrated. Moreover, a simple and precise UV spectrophotometric technique was used for the determination in dissolution analysis. Linear dependency of UV spectrophotometric method lies in the concentration range of 10 to 30 μg/mL. These proposed methods were sensitive, accurate, repeatable and useful for the routine determination of quetiapine in the tablets.