Validation of a selective method for determination of paroxetine in human plasma by LC-MS/MS.
J Pharm Pharm Sci
; 8(2): 340-7, 2005 Aug 17.
Article
em En
| MEDLINE
| ID: mdl-16124946
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Química Farmacêutica
/
Paroxetina
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
/
Adult
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2005
Tipo de documento:
Article