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2. Validated method for determination of bromopride in human plasma by liquid chromatography-electrospray tandem mass spectrometry: application to the bioequivalence study

Author

Nazare, P., primary, Massaroti, P., additional, Duarte, L. F., additional, Campos, D. R., additional, Marchioretto, M. A. M., additional, Bernasconi, G., additional, Calafatti, S., additional, Barros, F. A. P., additional, Meurer, E. C., additional, Pedrazzoli, J., additional, and Moraes, L. A. B., additional

Published
2005
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3. Validation of a selective method for determination of paroxetine in human plasma by LC-MS/MS

Author

Massaroti P, Nm, Cassiano, Lf, Duarte, Dr, Campos, Ma, Marchioretto, Bernasconi G, Calafatti S, Fa, Barros, Eduardo Cesar Meurer, and Pedrazzoli J

Subjects
Adult, Male, Paroxetine, Cross-Over Studies, Adolescent, Chemistry, Pharmaceutical, Humans, Mass Spectrometry, Chromatography, Liquid
Abstract

A sensitive, robust, and selective liquid chromatographic-tandem mass spectrometric method (LC-MS/MS) was developed and validated for paroxetine quantification in human EDTA plasma.Sample preparation was based on liquid-liquid extraction using a mixture of ethyl acetate/hexane (50/50; v/v) to extract the drug and internal standard from plasma. Chromatography was performed on a C-18 analytical column and the retention times were 1.6 and 1.7 for paroxetine and fluoxetine (IS), respectively. The ionization was optimized using ESI(+) and selectivity was achieved by tandem mass spectrometric analysis using MRM functions, 330.0 --70.0 and 310 --43.9 for paroxetine and fluoxetine.Analytical curve ranged from 0.2 to 20.0 ng/mL. Inter-day precision and accuracy of the quality control (QC) samples were15% relative standard deviation (RSD). Analyte stability during sampling processing and storage were established.Validation results on linearity, specificity, accuracy, precision as well as application to the analysis of samples taken up to 120 h after oral administration of 20 mg of paroxetine in 28 healthy volunteers were found to be of good performance in bioequivalence study.

5. Validation of a selective method for determination of paroxetine in human plasma by LC-MS/MS.

Author

Massaroti P, Cassiano NM, Duarte LF, Campos DR, Marchioretto MA, Bernasconi G, Calafatti S, Barros FA, Meurer EC, and Pedrazzoli J

Subjects
Adolescent, Adult, Chromatography, Liquid methods, Cross-Over Studies, Humans, Male, Mass Spectrometry methods, Paroxetine chemistry, Chemistry, Pharmaceutical methods, Paroxetine blood
Abstract

Purpose: A sensitive, robust, and selective liquid chromatographic-tandem mass spectrometric method (LC-MS/MS) was developed and validated for paroxetine quantification in human EDTA plasma., Methods: Sample preparation was based on liquid-liquid extraction using a mixture of ethyl acetate/hexane (50/50; v/v) to extract the drug and internal standard from plasma. Chromatography was performed on a C-18 analytical column and the retention times were 1.6 and 1.7 for paroxetine and fluoxetine (IS), respectively. The ionization was optimized using ESI(+) and selectivity was achieved by tandem mass spectrometric analysis using MRM functions, 330.0 --> 70.0 and 310 --> 43.9 for paroxetine and fluoxetine., Results: Analytical curve ranged from 0.2 to 20.0 ng/mL. Inter-day precision and accuracy of the quality control (QC) samples were < 15% relative standard deviation (RSD). Analyte stability during sampling processing and storage were established., Conclusion: Validation results on linearity, specificity, accuracy, precision as well as application to the analysis of samples taken up to 120 h after oral administration of 20 mg of paroxetine in 28 healthy volunteers were found to be of good performance in bioequivalence study.

Published
2005

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