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Titolo:
Gabapentin quantification in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Application to bioequivalence study
Autore:
Ifa, DR; Falci, M; Moraes, ME; Bezerra, FAF; Moraes, MO; de Nucci, G;
Indirizzi:
Univ Sao Paulo, Cartesius Analyt Unit, Dept Pharmacol, ICB, BR-05508900 Sao Paulo, Brazil Univ Sao Paulo Sao Paulo Brazil BR-05508900 BC05508900 Sao Paulo, Brazil Fed Univ Ceara, Dept Pharmacol, BR-60431970 Ceara, Brazil Fed Univ Ceara Ceara Brazil BR-60431970 BCcol, BR-60431970 Ceara, Brazil
Titolo Testata:
JOURNAL OF MASS SPECTROMETRY
fascicolo: 2, volume: 36, anno: 2001,
pagine: 188 - 194
SICI:
1076-5174(200102)36:2<188:GQIHPB>2.0.ZU;2-C
Fonte:
ISI
Lingua:
ENG
Soggetto:
SOLID-PHASE EXTRACTION; FLUOROMETRIC DETECTION; GAS-CHROMATOGRAPHY; SERUM; VIGABATRIN; URINE; HPLC;
Keywords:
gabapentin; human plasma; chromatography; mass spectrometry;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Physical, Chemical & Earth Sciences
Citazioni:
20
Recensione:
Indirizzi per estratti:
Indirizzo: Ifa, DR Jesuino Marcondes Machado 415, BR-13092320 Campinas, SP, Brazil Jesuino Marcondes Machado 415 Campinas SP Brazil BR-13092320 BCil
Citazione:
D.R. Ifa et al., "Gabapentin quantification in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Application to bioequivalence study", J MASS SPEC, 36(2), 2001, pp. 188-194

Abstract

A rapid, sensitive and specific analytical method was developed and validated to quantify gabapentin in human plasma using acetaminophen as an internal standard. The method employs a single plasma protein precipitation. The analytes are chromatographed on a C-4 reversed-phase chromatographic columnand analyzed by mass spectrometry in the multiple reaction monitoring (MRM) mode. The method has a chromatographic run time of 4 min and a linear calibration curve over the range 50-10000 ng ml(-1) (I. > 0.999). The between-run precision, based on the relative standard deviation for replicate quality controls, was less than or equal to 14.8 % (200 ng ml(-1)), 6.0% (1000 ng ml(-l)) and 4.4% (5000 ng ml-l). The between-run accuracy was +/-2.6, 4.4and 0.5% for the above-mentioned concentrations, respectively. This methodwas employed in a bioequivalence study of two gabentin capsule formulations (Progresse from Biosintetica, Brazil, as a test formulation, and Neurotinfrom Parke-Davis, as a reference formulation) in 24 healthy volunteers of both sexes who received a single 300 mg dose of each formulation. The studywas conducted using an open, randomized, two-period crossover design with a 7-day washout interval. The 90% confidence interval (CI) of the individual ratio geometric mean for Progresse/Neurotin was 87.9-115.6% for AUC((0-36) (h)) and 88.6-111.7% for C-max. Since both 90% CI for AUC((0-36 h)) and C-max were included in the 80-125% interval proposed by the US Food and DrugAdministration, Progresse was considered bioequivalent to Neurotin according to both the rate and extent of absorption. Copyright (C) 2001 John Wiley& Sons, Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 19/01/20 alle ore 20:27:27