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1.
Future Sci OA ; 5(5): FSO374, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31245038

RESUMO

AIM: A rapid UPLC-MS/MS method for the determination of tamoxifen (TAM), N-desmethyltamoxifen, 4-hydroxytamoxifen and endoxifen in human plasma was validated, after a simple protein precipitation. MATERIALS AND METHODS: The analysis was achieved on a C18 analytical column, using a gradient elution with a mobile phase of water and acetonitrile for 4.5 min. RESULTS: The validated method demonstrated good linearity between 1 and 500 ng/ml for TAM and N-desmethyltamoxifen; between 0.2 and 100 ng/ml for endoxifen and between 0.1 and 50 ng/ml for 4-hydroxytamoxifen. The method also provided satisfactory results in terms of within day and between day imprecisions and accuracy, and also in terms of time stability and specificity. CONCLUSION: The method is applied routinely for TAM monitoring from patients undergoing therapy.

2.
J Anal Toxicol ; 37(7): 433-9, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23828102

RESUMO

A wipe-sampling procedure followed by a simple liquid chromatography-mass spectrometry method was developed and validated for the simultaneous quantification of three cytotoxic drugs [5-fluorouracil (5FU), doxorubicin and cyclophosphamide (CP)] for the determination of surface contamination. After a solid-phase extraction procedure with wiping filter paper, the separation was performed within 30 min using a gradient mobile phase. The method was validated according to the recommendations of the US Food and Drug Administration. Wiping was performed using Whatman(®) filter paper on different surfaces such as stainless steel, polypropylene and glass. The method was linear, between 10 and 500 ng per wiping sample (i.e., 0.1-5 ng/cm(2)) for 5FU and doxorubicin, and between 1-100 ng per wiping sample (i.e., 0.01-1 ng/cm(2)) for CP. The lower limits of detection and quantification were 5 and 10 ng per wiping sample for 5FU and doxorubicin, and 0.5 and 1 ng per wiping sample for CP. This new sensitive methodology for surface contamination studies was successfully applied on commercial vials and different places in a cancer research hospital. This approach is particularly suitable to assess the risk of occupational exposure to cytotoxic drugs and to optimize the cleaning process, especially for the most toxic molecule studied, CP.


Assuntos
Antibióticos Antineoplásicos/análise , Antimetabólitos Antineoplásicos/análise , Antineoplásicos Alquilantes/análise , Ciclofosfamida/análise , Doxorrubicina/análise , Fluoruracila/análise , Calibragem , Cromatografia Líquida de Alta Pressão , Contaminação de Equipamentos , Indicadores e Reagentes , Limite de Detecção , Espectrometria de Massas , Exposição Ocupacional/análise , Papel , Controle de Qualidade , Padrões de Referência , Reprodutibilidade dos Testes , Soluções
3.
Ther Drug Monit ; 33(6): 705-10, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22105587

RESUMO

A simple liquid chromatography-mass spectrometry method was developed and validated for quantification of sorafenib (Nexavar) in human plasma. After a solid-phase extraction procedure, the separation was performed within 2 minutes using an isocratic flow of a mobile phase consisting of formic acid/acetonitrile applied on a C18 analytical column. The analyte was detected by mass spectrometry in the single-ion monitoring mode. The method was validated according to the recommendations of the US Food and Drug Administration. The method was linear (r² > 0.99) between 10 and 10,000 ng/mL. The lower limits of detection and quantification were 5 and 10 ng/mL, respectively. Within-day and between-day imprecisions were less than 10.4%, and inaccuracy did not exceed 8.7%. The mean extraction recovery was 92.2%. The method also provided satisfactory results in terms of time stability and dilution integrity. Sorafenib plasma concentrations of the studied patient ranged between 1831 and 3459 ng/mL. This new technique is rapid, sensitive, and was applied to the determination of sorafenib plasma concentrations in a patient undergoing hemodialysis. Our results indicate that sorafenib is not cleared from plasma by hemodialysis, although analysis should be delayed after dialysis to avoid erratic fluctuations.


Assuntos
Antineoplásicos/sangue , Benzenossulfonatos/sangue , Falência Renal Crônica/sangue , Inibidores de Proteínas Quinases/sangue , Piridinas/sangue , Diálise Renal , Antineoplásicos/farmacocinética , Antineoplásicos/uso terapêutico , Benzenossulfonatos/farmacocinética , Benzenossulfonatos/uso terapêutico , Calibragem , Carcinoma Hepatocelular/complicações , Carcinoma Hepatocelular/tratamento farmacológico , Cromatografia Líquida de Alta Pressão , Estabilidade de Medicamentos , Evolução Fatal , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/metabolismo , Falência Renal Crônica/terapia , Limite de Detecção , Neoplasias Hepáticas/complicações , Neoplasias Hepáticas/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Niacinamida/análogos & derivados , Compostos de Fenilureia , Inibidores de Proteínas Quinases/farmacocinética , Inibidores de Proteínas Quinases/uso terapêutico , Piridinas/farmacocinética , Piridinas/uso terapêutico , Reprodutibilidade dos Testes , Extração em Fase Sólida , Sorafenibe , Espectrometria de Massas por Ionização por Electrospray
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