Lu Jun, Rustum Abu M
The Schering-Plough Pharmaceutical Company, GQS-AS, Union, NJ 07083, USA.
J Chromatogr Sci. 2008 Jul;46(6):466-71. doi: 10.1093/chromsci/46.6.466.
A normal-phase enantioselective high-performance liquid chromatographic method is developed for the separation of the undesired enantiomer from T-3811ME and quantitaion of the undesired enantiomer at low levels using a Chiralpak AD-H column (4.6 x 150 mm) packed with modified amylose stationary phase. The 2% water-modified 2-propanol is used for the method development activities, including exploration of various organic modifiers, optimization of additive acid concentration, column screening, and column temperature optimization. The final optimized method separated the undesired enantiomer from T-3811ME and is proven to be robust, sensitive, linear, accurate, and precise.
