Development of a high-performance liquid chromatographic-mass spectrometric assay for the specific and sensitive quantification of Ro 64-0802, an anti-influenza drug, and its pro-drug, oseltamivir, in human and animal plasma and urine.
J Chromatogr B Biomed Sci Appl
; 745(2): 373-88, 2000 Aug 18.
Article
em En
| MEDLINE
| ID: mdl-11043756
ABSTRACT
Oseltamivir phosphate (Ro 64-0796/002) is a pro-drug of the anti-influenza neuraminidase inhibitor, Ro 64-0802, and as Tamiflu, has been developed for the treatment of both A and B strains of the disease. This paper describes an HPLC-MS-MS assay for both compounds in plasma and urine which fulfils all of the criteria for a good analytical method. It is sensitive with limits of quantification of 1 and 10 ng/ml for the pro-drug and active neuraminidase inhibitor, respectively. It is both accurate and precise with typical coefficients of variation from some 5,000 quality control samples of approximately +/-3 and +/-6%, respectively. Extensive stability studies have demonstrated the absence of significant problems associated with the decomposition of either compound, although ex vivo hydrolysis of Ro 64-0796 to Ro 64-0802 in rodent plasma has to be prevented by the use of the esterase inhibitor, dichlorvos.
Buscar no Google
Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Cromatografia Líquida de Alta Pressão
/
Acetamidas
Idioma:
En
Ano de publicação:
2000
Tipo de documento:
Article