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Biorelevant and Quality Control Dissolution Method Development and Validation of Quetiapine Fumarate Tablets

The aim of this study was to develop and validate Biorelevant and Quality control dissolution method for poorly water soluble drug Quetiapine Fumarate (QF). The Ultra Violet spectrophotometric method developed was based on the direct estimation method using 248 nm as λmax. The method was validated according to International Conference on Harmonization (ICH) guidelines which include precision, specificity, accuracy and linearity. The Biorelevant dissolution medium i.e., Blank Fed State Simulated Intestinal Fluid (FeSSIF) and Quality control dissolution medium i.e., 0.1N Hydro Chloric acid were selected on the basis of solubility studies. Stability studies were performed in respective dissolution mediums and the sample solutions were found to be stable for 2 days. The corresponding Biorelevant and Quality control dissolution profiles were constructed and the selected brands showed more than 85% drug release within 20 min. Thus, the proposed Biorelevant and Quality control dissolution methods can be used successfully. Keywords: Biorelevant, Dissolution, Quetiapine fumarate, UV spectrophotometry, Validation.

ACTA PHARMACEUTICA SCIENCIA Dergisi 55/7. Sayısı İçin Tıklayınız.