A Novel Validated Rp-HPLC Method for the Determination of Quetiapine Fumarate in Bulk and Pharmaceutical Tablet Dosage Forms: Application to Dissolution Study

Abstract

A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Quetiapine Fumarate in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Welchrom C18Column (4.6 X 250 mm, 5 µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10 mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50 v/v). The flow rate was set to 1.0 mL.min-1 with the responses measured at 230 nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Quetiapine Fumarate was found to be 3.260 minutes. Linearity was established for Quetiapine Fumarate in the range of 2-10 µg.mL-1 with correlation coefficient 0.9999. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Quetiapine Fumarate in pharmaceutical tablet dosage form