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Quantification of nimesulide in human plasma by high-performance liquid chromatography/tandem mass spectrometry. Application to bioequivalence studies

Barrientos-Astigarraga, Rafael Eliseo ; Vannuchi, Yuri Borges ; Sucupira, Mauro ; Moreno, Ronilson Agnaldo ; Muscará, Marcelo Nicolás ; Nucci, Gilberto De

Journal of mass spectrometry., 2001-12, Vol.36 (12), p.1281-1286 [Periódico revisado por pares]

Chichester, UK: John Wiley & Sons, Ltd

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Título:
Quantification of nimesulide in human plasma by high-performance liquid chromatography/tandem mass spectrometry. Application to bioequivalence studies
Autor: Barrientos-Astigarraga, Rafael Eliseo ; Vannuchi, Yuri Borges ; Sucupira, Mauro ; Moreno, Ronilson Agnaldo ; Muscará, Marcelo Nicolás ; Nucci, Gilberto De
Assuntos: Adolescent ; Adult ; Analysis ; bioavailability ; Biological and medical sciences ; biological matrices ; celecoxib ; Chromatography, High Pressure Liquid - methods ; Drug Stability ; electrospray ; Ether ; Female ; General pharmacology ; high-performance liquid chromatography/tandem mass spectrometry ; Humans ; Male ; Mass Spectrometry - methods ; Medical sciences ; Methylene Chloride ; Middle Aged ; pharmacokinetics ; Pharmacology. Drug treatments ; Quality Control ; Sensitivity and Specificity ; Sulfonamides - administration & dosage ; Sulfonamides - blood ; Sulfonamides - pharmacokinetics ; Therapeutic Equivalency
É parte de: Journal of mass spectrometry., 2001-12, Vol.36 (12), p.1281-1286
Notas: ArticleID:JMS232
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Descrição: A method based on liquid chromatography with negative ion electrospray ionization and tandem mass spectrometry is described for the determination of nimesulide in human plasma. Liquid–liquid extraction using a mixture of diethyl ether and dichloromethane was employed and celecoxib was used as an internal standard. The chromatographic run time was 4.5 min and the weighted (1/x) calibration curve was linear in the range 10.0–2000 ng ml−1. The limit of quantification was 10 ng ml−1, the intra‐batch precision was 6.3, 2.1 and 2.1% and the intra‐batch accuracy was 3.2, 0.3 and 0.1% for 30, 300 and 1200 ng ml−1 respectively. The inter‐batch precision was 2.3, 2.8 and 2.7% and the accuracy was 3.3, 0.3 and 0.1% for 30, 300 and 1200 ng ml−1 respectively. This method was employed in a bioequivalence study of one nimesulide drop formulation (nimesulide 50 mg ml−1 drop, Medley S/A Indústria Farmacêutica, Brazil) against one standard nimesulide drop formulation (Nisulid, 50 mg ml−1 drop, Astra Médica, Brazil). Twenty‐four healthy volunteers (both sexes) took part in the study and received a single oral dose of nimesulide (100 mg, equivalent to 2 ml of either formulation) in an open, randomized, two‐period crossover way, with a 2‐week washout interval between periods. The 90% confidence interval (CI) for geometric mean ratios between nimesulide and Nisulid were 93.1–109.6% for Cmax, 87.7–99.8% for AUClast and 88.1–99.7% for AUC0–∞. Since the 90% CI for the above‐mentioned parameters were included in the 80–125% interval proposed by the US Food and Drug Administration, the two formulations were considered bioequivalent in terms of both rate and extent of absorption. Copyright © 2001 John Wiley & Sons, Ltd.
Editor: Chichester, UK: John Wiley & Sons, Ltd
Idioma: Inglês

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Quantification of nimesulide in human plasma by high-performance liquid chromatography/tandem mass spectrometry. Application to bioequivalence studies

Barrientos-Astigarraga, Rafael Eliseo ; Vannuchi, Yuri Borges ; Sucupira, Mauro ; Moreno, Ronilson Agnaldo ; Muscará, Marcelo Nicolás ; Nucci, Gilberto De

Chichester, UK: John Wiley & Sons, Ltd

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