Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Stress Testing of Quetiapine Fumarate by a Chemometric Assisted Multi-Component Ion-Interaction System


Suryakanta Swain and Prafulla Kumar Sahu

Classical experimental designs have been popularly employed in establishing robust analytical methods while achieving other advantages, viz., reduction in the number of experiments and hence lower reagent consumption and less laboratory work. To achieve optimum chromatographic condition, a computer-aided Box-Behnken Design (BBD) in ion-pairing stability-indicating RP-HPLC assay of quetiapinefumarate along with its stress related substances has been investigated here, proving to be an invaluable tool in ascertaining a reliable method. The study includes forced degradation of quetiapinefumarateunder acidic, alkaline, photo, oxidative and peroxide stress conditions followed by separation of degradation products. Critical factors including buffer pH, % organic phase (acetonitrile) and concentration of hexane sulphonate (ion-pairing reagent) susceptible to influence the separation (critical resolutions) and total analysis time were investigated by response surface methodology. The best optimal separation condition as obtained was observed on an enable C-18 column (250mm x 4.6mm i.d, 5μm particle size) using mobile phase composed of Phosphate buffer (pH 2.0) containing 0.002mM hexane sulphonate and acetonitrile (74.4:25.6 v/v) at a flow rate of 1.00ml/min. The eluents were observed at 220nm using a PDA detector. Further, the method was validated to ensure its reliability and other regulatory criteria are met.


Share this article

Google Scholar citation report
Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

Pharmaceutical Regulatory Affairs: Open Access peer review process verified at publons

Indexed In

arrow_upward arrow_upward