Journal
JOURNAL OF CHROMATOGRAPHY B
Volume 745, Issue 2, Pages 373-388Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/S0378-4347(00)00300-5
Keywords
Ro 64-0802; oseltamivir
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Oseltamivir phosphate (Ro 64-0796/002) is a pro-drug of the anti-influenza neuraminidase inhibitor, Ro 64-0802, and as Tamiflu(TM), 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 5000 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. (C) 2000 Elsevier Science B.V. All rights reserved.
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