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.

摘要: 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 treatment both A B strains disease. This paper describes an HPLC-MS-MS assay compounds in plasma urine which fulfils all criteria good analytical method. It sensitive with limits quantification 1 10 ng/ml active respectively. accurate precise typical coefficients variation from some 5,000 quality control samples approximately +/-3 +/-6%, Extensive stability studies have demonstrated absence significant problems associated decomposition either compound, although ex vivo hydrolysis 64-0796 to 64-0802 rodent be prevented by use esterase dichlorvos.