Quetiapine Fumarate Case Study

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Introduction: Quetiapine Fumarate (QF) is a psychotropic agent indicated for the treatment of schizophrenia and manic episodes associated with bipolar disorder. QF possesses good solubility in aqueous fluids (1) and ethanol. Quetiapine is available in the market with the brand name of Seroquel XL (2). Inadvertent, rapid drug release in a small period of time of the entire amount or a significant fraction of the drug contained in a prolonged release dosage form is often referred to as “dose dumping”. Jhonson F. et al. highlighted that in United States, the dose dumping in general and alcohol induced dose dumping in particular is considered as a serious concern for orally administered prolonged release dosage forms (3). Subjuct to the therapeutic …show more content…

The mobile phase used was a mixture of ammonium acetate buffer and acetonitrile at a ratio of 400:600. A flow rate of 1 mL/min was maintained, and the detection wavelength was 292 nm (22). The required studies were carried out to estimate the precision and accuracy of the HPLC method and were found to be within limits [percent coefficient of variation was less than 15%]. Sample preparation briefly involved 0.4 μ membrane filter through which the sample was filtered, diluted with mobile phase, and 10 μL was spiked into …show more content…

The predicted and experimental responses are compared in order to validate the model and to calculate the prediction error. The prediction error was found to be below 7% indicating that the observed responses were very close to the predicted values. Percentage prediction error is useful in constituting the validity of generated equations and describes how close the predicted responses to that of actual values. The values of <15 are desirable to have closeness of the predicted values with the actual values