Analytical Method Development and Validation of Quetiapine Fumarate in API and Dosage form by Using RP-HPLC

RP-HPLC method developed is a simple, precise and functional technique for the calculation of amount of Quetiapine fumarate from marketed tablets and bulk form. The RP-HPLC analysis was carried out on Hyper chrome ODS-BP 5 mu m column (4.6mmx200mm) using a mobile phase 0.1% Orthophoshoric acid and Acetonitrile (80:20v/v) with pH 5.5. Quetiapine fumarate quantified by using UV detector at 210nm. The retention time of the Quetiapine fumarate was found to be 2.6 minute. The linearity of the drug concentration ranges from 20-400 mu g/mL. The detection and quantification limits were intended at 3.70 mu g/mL and 12.35 mu g/mL. The precision, accuracy, specificity, robustness and degradation studies were validated.