Control of Enantiomeric purity of Pharmaceuticals

Dosage concentration of a racemic drug is an illusion to the patients as well to the practicing physicians because they are not aware of the fact that the two enantiomers have different pharmacodynamics and pharmacokinetics. Thus, the production and marketing of pure enantiomeric drug is of critical importance. USFDA and other regulatory agencies require complete information on both the enantiomers along with the details of methods of separation and control of enantiomeric purity before a new enantiomeric mixture is approved. Therefore, the development of reliable and sensitive analytical methods are gaining importance and are the need of the hour. This publication reports several such new methods using liquid chromatography.