期刊
JOURNAL OF CHROMATOGRAPHY A
卷 914, 期 1-2, 页码 23-27出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/S0021-9673(00)01089-X
关键词
preparative chromatography; pharmaceutical analysis; flutamide
Flutamide, marketed as Eulexin, is used for treatment of metastic prostatic carcinoma. Purity of a radiolabeled batch for metabolism studies was first determined by reversed-phase HPLC on a 5 mum, 150X4.6 mm analytical column. The separation was then scaled up to give a semipreparative column (5 mum, 250X10 mm) purification procedure. Fraction analysis was done on a short rapid analysis (5 mum, 50X3.0 mm) column. Analysis of the final product was performed on the analytical column. All columns were YMC-Pack ODS-AQ. The analytical work involved large mass injections in order to have the required amounts of radioactivity needed for accurate impurity profile determinations, and the preparative work involved masses much larger than the calculated scale-up values. Ultraviolet and radiochromatograms of the drug on the various column configurations are compared. A 95.7% recovery of product was obtained, with radiochemical purity increased from 95.0 to 99.8%. (C) 2001 Elsevier Science B.V. All rights reserved.
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