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Zarna Ronak Dedania*, Ronak Ratilal Dedania and Navin R. Sheth


The objective of the current study was to develop a validated stabilityindicating assay method (SIAM) for Quetiapine fumarate after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis and thermal stress conditions. The liquid chromatographic separation was achieved on a symmetry achieved on a C18 column (250 × 4.6 mm i.d., 5 μm) using methanol: acetonitrile: water (67:16:17) at a flow rate of 1 ml/min at ambient temperature with retention time 5.35 min. at 220 nm detection wavelength. The method was linear in concentration range 10-50 μg/ml (r2 = 0.998) with a limit of detection and quantitation of 3.27 μg/ml and 9.92 μg/ml, respectively. The method was validated with respect to linearity, precision (including intermediate precision), accuracy and specificity. The R.S.D. values for intra- and inter-day precision studies were < 1.02 % and < 1.15 %, respectively. The recovery of the drug ranged 99.68 ± 1.67 % to 100.37 ± 1.34 % from pharmaceutical dosage form. Degradation products resulting from the stress studies did not interfere with the detection of Quetiapine fumarate and the assay is thus stability-indicating.

Keywords: Quetiapine fumarate; Stability-indicating Assay; Stress testing; High Performance Liquid Chromatography.

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