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

of quality control data for Paroxetine in Bovine plasma

Table 2: Intra-batch accuracy and precision of calibration data for Paroxetine in Bovine Plasma
*Calibration data sets 1 and 8 used to construct curve Discussion The lowest calibration standard selected for this assay at 0.1 pg/L had a minimum signal-to-noise of greater than 5:1 and variability of 3% from eight determinations. This was well within the acceptance criteria set by the guidelines which defines that the Limit of Quantitation (LOQ) of an assay should have less than 20% variability.

The Intra-batch variability of back-calculated concentrations of Paroxetine in Bovine Plasma was less than 3% across the whole calibration range. This falls well within the expected method validation acceptance criteria as set by Shah et al of 20% variability at the LOQ and less than 15% variability at all other concentrations of the calibration standards.

The validated method accuracy and precision were determined from the backcalculated values of the Quality Control samples. The intra-batch accuracy was 103.6%, 104.0% and 99.7% at concentrations of 0.3, 25 and 750 pg/L respectively. The intra-batch precision was 2.2%, 0.6% and 0.6% at concentrations of 0.3, 25 and 750 pg/L respectively.

The validation data indicate that the TSQ Quantum is sensitive, robust and linear (four orders of dynamic range demonstrated here) and is an ideal instrument for the quantitation of analytical substances in Biological matrices. References 1 Shah, V.P., et al, Pharmaceutical Rese
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Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
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