On-line solid-phase extraction coupled with high-performance liquid chromatography and tandem mass spectrometry (SPE-HPLC-MS-MS) for quantification of bromazepam in human plasma: An automated method for bioequivalence studies

Therapeutic Drug Monitoring

Volumn 27, Issue 5, 2005, Pages 601-607

  Saraiva Gonçalves, José Carlos ^a,b   Monteiro, Tânia Maria ^a   De Miranda Neves, Claúdia Silvana ^a   Da Silva Gram, Karla Regina ^a   Volpato, Nádia Maria ^a   Silva, Vivian A ^a   Caminha, Ricardo ^b   Bencke Gonçalves, Maria Do Rocio ^b   Dos Santos, Fábio Monteiro ^b   Da Silveira, Gabriel Estolano ^b   Noël, François ^b  

^a Faculdade de Farmacia   (Brazil)

^b FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

Author keywords

Bioequivalence; Bromazepam; Dissolution profile; LC MS MS; SPE

Indexed keywords

BROMAZEPAM; CARBAMAZEPINE;

AREA UNDER THE CURVE; ARTICLE; AUTOMATION; BIOEQUIVALENCE; CENTRIFUGATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DETERMINATION; DRUG HALF LIFE; DRUG SOLUBILITY; ELECTROSPRAY MASS SPECTROMETRY; GEOMETRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IONIZATION; NORMAL HUMAN; ONLINE ANALYSIS; PLASMA; PRIORITY JOURNAL; QUANTITATIVE ASSAY; SOLID PHASE EXTRACTION; TABLET FORMULATION; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

ADULT; AREA UNDER CURVE; BROMAZEPAM; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; MALE; MIDDLE AGED; QUALITY CONTROL; SOLUBILITY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; THERAPEUTIC EQUIVALENCY;

EID: 26444615783     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ftd.0000170027.28949.da     Document Type: Article

References (19)

1. Solleu HL, Demotes-Mainard F, Vinçon G, et al. The determination of bromazepam in plasma by reversed-phase high-performance liquid chromatography. J Pharm Biomed Anal. 1993;11:771-775.
2. Tjaden UR, Meeles MTHA, Thys CP, et al. Determination of some benzodiazepines and metabolites in serum, urine and saliva by high-performance liquid chromatography. J Chromatogr. 1980;181:227-241.
3. Capella-Peiró ME, Bose D, Martinavarro-Dominguez A, et al. Direct injection micellar liquid cromatographic determination of benzodiazepines in serum. J Chromatogr B. 2002;780:241-249.
4. Aebi B, Sturny-Jungo R, Bernhard W, et al. Quantitation using GC-TOF-MS: example of bromazepam. Forensic Sci Int. 2002;128:84-89.
5. Salem AEA, Barsoum BN, Saad GR, et al. Potentiometric determination of some 1,4-benzodiazepines in pharmaceutical preparations and biological samples. J Electroanal Chem. 2002;536:1-9.
6. Kleinschnitz M, Herderich M, Schreier P. Determination of 1,4-benzodiazepines by high-performance liquid chromatography-electrospray tandem mass spectometry. J Chromatogr Biomed Appl. 1996;676:61-67.
7. McClean S, O'Kane E, Hillis J, et al. Determintion of 1,4-benzodiazepines and their metabolites by capillary electrophoresis and high-performance liquid cromatography using ultraviolet and electrospray ionisation mass spectometry. J Chromatogr A. 1999;838:273-291.
8. McClean S, O'Kane EJ, Smyth WF. Electrospray ionization-mass spectrometric characterisation of selected anti-psychotic drugs and their detection and determination in human hair samples by liquid chromatography- tandem mass spectometry. J Chromatogr B. 2000;740:141-157.
9. Liu Z, Short J, Rose A, et al. The simultaneous determination of diazepam and its three metabolites in dog plasma by high-performance liquid chromatography with mass spectroscopy detection. J Pharm Biomed Anal. 2001;26:321-330.
10. Redrup MJ, Leaf FC, Miyashita A, et al. Validation of a liquid chromatographic-tandem mass spectrometric method for the measurement of (R)-1-[2,3-dihydro-2-oxo-1-pivaloymethyl-5-(2-pyridyl)-1H-1,4-benzodiazepin-3- yl]-3-(3-methylaminophenyl)urea (YF476) in human plasma. J Chromatogr B. 2002;772:317-325.
11. Pirnay S, Ricordel I, Libong D, et al. Sensitive method for the detection of 22 benzodiazepines by gas chromatography-ion trap tandem mass spectrometry. J Chromatogr A. 2002;954:235-245.
12. Borrey D, Meyer E, Lambert W, et al. Comparison of quadrupole and (quadrupole) ion-trap mass spectrometers for the analysis of benzodiazepines. J Chromatogr A. 1998;819:125-131.
13. The United States Pharmacopoeia, 27th ed. Rockville, MD: United States Pharmacopoeia Convention Inc, 2004.
14. RE 901 Guia para Ensaio de Dissolução Para Formas Farmacêuticas Sólidas Orais de Liberação Imediata. ANVISA/MS/Brazil. May 2003.
15. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Rockville, MD: CDER, Food and Drug Administration, 1997.
16. The United States Pharmacopoeia, 24th ed. Rockville, MD: United States Pharmacopoeia Convention Inc., 2000.
17. Panderi I, Archontaki H, Gikas E, et al. Acidic hydrolysis of bromazepam studied by high performance liquid chromatography. Isolation and identification of its degradation products. J Pharm Biomed Anal. 1998;17:327-335.
18. Berrueta LA, Gallo B, Vicent F. Biopharmacological data and high-performance liquid chromatographic analysis of 1,4-benzodiazepines in biological fluids: a review. J Pharm Biomed Anal. 1992;10:109-136.
19. Volpato NM, Silva RL, Brito APP, et al. In vitro/in vivo correlation of dissolution profiles of two L-thyroxine tablets with pharmacokinetics data obtained in patients with hypothyroidism. Eur J Pharm Sci. 2004;21:655-660.