STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF QUETIAPINE FUMARATE IN BULK AS WELL AS IN PHARMACEUTICAL DOSAGE FORM

Abstract

This study was designed to develop and validate a simple, sensitive, precise, and specific stability indicating reverse phase high-performance liquid chromatographic (HPLC) method for estimation of Quetiapine Fumarate in bulk and its tablet dosage form. The HPLC separation was carried out by reverse phase chromatography on Thermo column Symmetry C18 (4.6 x 150mm, 5 mm) with a mobile phase composed Sodium dihydrogen phosphate and the pH was adjusted to 4.0 by Orthophosporic Acid & Methanol in the ratio of 35:65 v/v in isocratic mode at a flow rate of 1.0 ml/min. The run time was maintained for 6mins. The detection was monitored at 290 nm. The calibration curve for Quetiapine Fumarate was linear from 20 to60 µg/ml. The inter-day and intra-day precision was found to be within the limits. The proposed method was adequate sensitivity, reproducibility, and specificity for the determination of Quetiapine Fumarate in bulk and its tablet dosage forms. The limit of detection [LOD] and limit of quantification [LOQ] for Quetiapine Fumarate were found to be 0.01 µg/ml and 0.03 µg /ml respectively. The Accuracy recoveries were 100.0-100.4% and reproducibility was found to be satisfactory. The bulk active pharmaceutical ingredient was subjected to  thermal,  photolytic,  hydrolytic  (acidic  and  basic)  and  oxidative  stress  conditions  and  stressed  samples  were analyzed by the proposed method. The method was validated in terms of linearity, precision, accuracy, specificity and robustness. All the validation was done as per ICH guidelines. The proposed method was simple, fast, accurate, and precise for the quantification of Quetiapine Fumarate in the dosage form, bulk drugs as well as for routine analysis in quality control.

Key-Words: Quetiapine Fumarate, RP-HPLC, ICH, Stability Indicating Studies, LOD, LOQ.