Please use this identifier to cite or link to this item:
Type: Artigo
Title: Quantification of chlordesmethyldiazepam by liquid chromatography–tandem mass spectrometry : application to a cloxazolam bioequivalence study
Author: Oliveira‐Silva, Diogo
Oliveira, Celso H.
Mendes, Gustavo D.
Galvinas, Paulo Alexandre R.
Barrientos‐Astigarraga, Rafael E.
De Nucci, Gilberto
Abstract: A rapid, sensitive and specific LC‐MS/MS method was developed and validated for quantifying chlordesmethyldiazepam (CDDZ or delorazepam), the active metabolite of cloxazolam, in human plasma. In the analytical assay, bromazepam (internal standard) and CDDZ were extracted using a liquid‐liquid extraction (diethyl‐ether/hexane, 80/20, v/v) procedure. The LC‐MS/MS method on a RP‐C18 column had an overall run time of 5.0 min and was linear (1/x weighted) over the range 0.5–50 ng/mL (R > 0.999). The between‐run precision was 8.0% (1.5 ng/mL), 7.6% (9 ng/mL), 7.4% (40 ng/mL), and 10.9% at the low limit of quantification—LLOQ (0.500 ng/mL). The between‐run accuracies were 0.1, –1.5, –2.7 and 8.7% for the above mentioned concentrations, respectively. All current bioanalytical method validation requirements (FDA and ANVISA) were achieved and it was applied to the bioequivalence study (Cloxazolam—test, Eurofarma Lab. Ltda and Olcadil®— reference, Novartis Biociências S/A). The relative bioavailability between both formulations was assessed by calculating individual test/reference ratios for Cmax, AUClast and AUC0‐inf. The pharmacokinetic profiles indicated bioequivalence since all ratios were as proposed by FDA and ANVISA
Subject: Cloxazolam
Cromatografia líquida
Country: Reino Unido
Editor: John Wiley & Sons
Rights: Fechado
Identifier DOI: 10.1002/bmc.1249Citations
Date Issue: 2009
Appears in Collections:FCM - Artigos e Outros Documentos

Files in This Item:
File Description SizeFormat 
000272071700004.pdf1.2 MBAdobe PDFView/Open

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.