Development and validation of assay method for estimation of quetiapine fumarate by RP-HPLC

Abstract

A simple, rapid, accurate and precise RP-HPLC method has been developed for estimation of Quetiapine Fumarate from tablet dosage form. Assay method was developed using Zorbax ODS C-18, 150 mm x 4.6 mm, 5.0 mm as stationary phase. Buffer:ACN (65:35) was used as mobile phase. % Assay was found to be 98.01-98.06. The method was validated in terms of linearity, precision, accuracy, specificity and robustness. All the validation were done as per ICH guidelines.