Determination of bromazepam in human plasma by high-performance liquid chromatography with electrospray ionization tandem mass spectrometric detection: Application to a bioequivalence study

Journal of Mass Spectrometry

Volumn 39, Issue 11, 2004, Pages 1348-1355

  Andraus, Maristela H ^a   Wong, Anthony ^b   Silva, Ovandir A ^b   Wada, Cicília Y ^c   Toffleto, Odaly ^d   Azevedo, Cristina P ^a   Salvadori, Myriam C ^a  

^a Chromanalysis SA   (Brazil)

^b Labs Maxilab Ana Lab SC Ltda   (Brazil)

^c Statpharm Assessoria Cie SC Ltda   (Brazil)

^d Kidney and Hypertension Hospital   (Brazil)

Author keywords

Bioequivalence; Bromazepam; Liquid chromatography tandem mass spectrometry; Lorazepam; Pharmacokinetics

Indexed keywords

BIOASSAY; DRUG DOSAGE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PLASMAS;

BIOEQUIVALENCE; BROMAZEPAM; HUMAN PLASMA; LORAZEPAM;

DRUG PRODUCTS;

BROMAZEPAM; LORAZEPAM;

ACCURACY; ADULT; ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD ANALYSIS; BLOOD STORAGE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG STABILITY; ELECTROSPRAY IONIZATION TANDEM MASS SPECTROMETRY; ELECTROSPRAY MASS SPECTROMETRY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID LIQUID EXTRACTION; MALE; NORMAL HUMAN; OPEN STUDY; PRIORITY JOURNAL; PROCESSING; PRODUCT RECOVERY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STANDARD; TANDEM MASS SPECTROMETRY;

ANTI-ANXIETY AGENTS; BROMAZEPAM; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; LORAZEPAM; PLASMA; REPRODUCIBILITY OF RESULTS; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; THERAPEUTIC EQUIVALENCY;

EID: 9144244391     PISSN: 10765174     EISSN: None     Source Type: Journal    
DOI: 10.1002/jms.667     Document Type: Article

References (16)

1. Noto AR, Carlini EA, Mastroianni PC, Alves VC, Galduróz JCF, Kuroiwa W, Csizmar J, Costa A, Faria MA, Hidalgo SR, Assis D, Nappo SA. Analysis of prescription and dispensation of psychotropic medications in two cities in the State of São Paulo, Brazill. Rev. Bras. Psiquiatr. 2002; 24: 68.
2. Jeantaud I, Haramburu F, Beagud B. Benzodiazepine consumption: survey of community pharmacies in Aquitane. Therapie 2001; 56: 15.
3. Agência Nacional de Vigilância Sanitária. Resolução 391/99. Diário Oficial da União: Brasília, 1999; 318.
4. SAS. Statistical Analysis System for Windows. SAS: Cary, NC, 1999-2000.
5. Hirayama H, Kasuya Y. High-performance liquid chromatographic determination of bromazepam in human plasma. J. Chromatogr. B 1983; 277: 414.
6. Heizmann P, Geschke R, Zinapold K. Determination of bromazepam in plasma and of its main metabolites in urine by reversed-phase high-performance liquid chromatography. J. Chromatogr. B 1984; 310: 129.
7. Boukhabza A, Lugnier AJ. High-performance liquid chromatographic determination of bromazepam in human plasma. Analyst 1989; 114: 639.
8. Le Solleu H, Demotes-Mainard F, Vincon G, Bannwarth B. The determination of bromazepam in plasma by reversed-phase high-performance liquid chromatography. J. Pharm. Biomed. Anal. 1993; 11: 771.
9. Tanaka E, Terada M, Misawa S, Wakasugi C. Simultaneous determination of twelve benzodiazepines in human serum using a new reversed-phase chromatographic column on a 2-microns porous microspherical silica gel. J. Chromatogr. B 1996; 682: 173; Erratum. J. Chromatogr. B 1998; 709: 324.
10. Tanaka E, Terada M, Misawa S, Wakasugi C. Simultaneous determination of twelve benzodiazepines in human serum using a new reversed-phase Chromatographic column on a 2-microns porous microspherical silica gel. J. Chromatogr. B 1996; 682: 173; Erratum. J. Chromatogr. B 1998; 709: 324.
11. Lerner FE, Schere D, Batafarano N, Casas F, Glancszpigel R. Comparative bioavailability of two oral formulations of bromazepam in healthy volunteers. Arzneim.-Forsch. 2001; 51: 955.
12. Capella-Peiro ME, Bose D, Martinavarro-Dominguez A, Gil-Agusti M, Esteve-Romero J. Direct injection micellar liquid chromatographic determination of benzodiazepines in serum. J. Chromatogr. B 2002; 780: 241.
13. Bogusz MJ. Liquid chromatography-mass spectrometry as a routine method in forensic sciences: a proof of maturity. J. Chromatogr. B 2000; 748: 3.
14. Estrela RCE, Salvadori MC, Raices RSL, Suarez-Kurtz G. Determination of didanosine in human serum by on-line solid phase extraction coupled to HPLC with ESI-MS/MS detection: application to a bioequivalence study. J. Mass Spectrom. 2003; 38: 378.
15. Raices RSL, Salvadori MC, Estrela RCE, Neto FRA, Suarez-Kurtz G. Determination of stavudine in human serum by on-line solid phase extraction coupled to high-performance liquid chromatography with electrospray ionization tandem mass spectrometry detection: application to a bioequivalence study. Rapid Commun. Mass Spectrom. 2003; 17: 1611.
16. Food and Drug Administration. In vivo bioequivalence guidances. Pharm. Forum 1993; 19: 6501.