Abstract
Three known impurities in oseltamivir phosphate bulk drug at level 0.1% (ranging from 0.05-0.1%) were detected by gradient reverse phase high performance liquid chromatography. These impurities were preliminarily identified by the mass number of the impurities. Different experiments were conducted and finally the known impurities were synthesized and characterized.
Highlights
Oseltamivir is an ester prodrug, which is rapidly and extensively hydrolysed in vivo to its active metabolite oseltamivir carboxylate, a potent and selective inhibitor of influenza virus neuraminidase[1] is considered the leading currently available antiviral to counter a serious epidemic or pandemic outbreak of influenza[2,3]
Sample was analyzed by High performance liquid chromatography (HPLC) and its purity was found to be 94.13%, molecular weight of oseltamivir phosphate impurity-A is 284.36,28 mass unit less than that of oseltamivir phosphate
Sample was analyzed by HPLC and its purity was found to be 92.61%, molecular weight of oseltamivir phosphate impurity-B is 284.36,28 mass unit less than that of oseltamivir phosphate
Summary
Oseltamivir is an ester prodrug, which is rapidly and extensively hydrolysed in vivo to its active metabolite oseltamivir carboxylate, a potent and selective inhibitor of influenza virus neuraminidase[1] is considered the leading currently available antiviral to counter a serious epidemic or pandemic outbreak of influenza[2,3]. There are several process impurities/related substances associated with the manufacture of oseltamivir phosphate. During the process development of oseltamivir phosphate three known impurities were identified in the analysis of different batches whose percent area ranged from 0.05-0.1% by HPLC12.
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