Development and Validation of RP-HPLC Method for Estimation of Quetiapine Fumarate in Pharmaceutical Formulations

Abstract

Objective : A simple, rapid, accurate and precise RP-HPLC method was developed for the determination of Quetiapinefumarate in pure and tablet dosage forms. Materials and Methods : Separation of the drug was achieved on aisocratic Shimadzu prominence HPLC instrument on a Waters Xterra C18 column (250x4.6 mm, 5 μ). Results : The method showed a linear response for concentration in the range of 50–150 μg/mL using buffer (9.2 ± 0.05) and acetonitrile in the ratio of 51:49 v/v with detection at 254 nm with a flow rate of 1.0 mL/min and retention time was 6.588 min. Conclusion: The method was statistically validated for linearity, accuracy, precision and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed, the %RSD from recovery studies was found to be less than 1. Key words: Quetiapinefumarate, Isocratic, C 18 , HPLC, Tablets.