( ...)Bioanalytical Method Intraday Validation for the Quantitation of Paroxetine ,,, in Bovine Plasma using the TSQ Quantum Mass Spectrometer

Mark Churchill and Mark Harrison, Thermo Finnigan, Hemel Hempstead, UK

Bioanalytical Method Validation

The data presented here can be acquired using a Thermo Finnigan TSQ Quantum mass spectrometer Introduction Guidelines on Bioanalytical Method Validation acceptance criteria were established by the US Food and Drug Administration (FDA) from a conference on Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies held in Arlington,VA, December 3-5, 1990.¹ These acceptance criteria were reviewed ten years on at Bioanalytical Methods Validation A Revisit with a Decade of Progress, Arlington,VA, January 12-14, 2000,² a meeting sponsored by the American Association of Pharmaceutical Scientists and the FDA. This led to the issue of the FDA Guidance for Industry document on Bioanalytical Method Validation in May 2001³. A full method validation should assess accuracy, precision, selectivity, sensitivity, reproducibility and stability of an analyte in matrix samples.

Paroxetine is an orally administered antidepressant which acts as a selective serotonin reuptake inhibitor (SSRI) but has only minimal effects on the neuronal reuptake of norepinephrine and dopamine. Paroxetine is administered for the treatment of depression, social anxiety disorder, obsessive compulsive disorder, panic disorder and generalized anxiety disorder. Goal This report describes the ease of use of the TSQ Quantum to validate bioanalytical methods in accordance with the guid
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