Krishna Reddy K V S R, Mahender Rao S, Om Reddy G, Suresh T, Moses Babu J, Dubey P K, Vyas K
Department of Analytical Research, Dr Reddy's Research Foundation, Bollaram Road, Miyapur, Hyderabad 500 050, India.
J Pharm Biomed Anal. 2002 Oct 15;30(3):635-42. doi: 10.1016/s0731-7085(02)00353-9.
Two unknown impurities in linezolid bulk drug at levels below 0.1% (ranging from 0.05 to 0.1%) were detected by a simple isocratic reverse phase high performance liquid chromatography (HPLC). These impurities were isolated from crude sample of linezolid using reverse phase preparative HPLC. Based on the spectroscopic data (IR, NMR and MS) the structures of the impurities were characterized as (S)-N-[[-(3-(3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl] acetate(I) and (S)-N-[[-(3-(3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl] chloride(II). The synthesis from an unambiguous route and the formation of impurities was discussed.
