CHROMATOGRAPHY, Vol. 33 (2012), No. 3, pp. -179

Pharmaceutical impurities arise during manufacturing and storage of both drug substances and drug products. These pharmaceutical impurities sometimes cause pharmacological and toxicological effects. Therefore, impurities need to be adequately controlled to assure the quality and safety of pharmaceuticals. As a consequence, identification and safety qualification are essential even for impurities present at small amounts. HPLC hyphenated techniques have been applied to identify pharmaceutical impurities since this approach enables rapid structural determination of low-level impurities without time-consuming isolation and purification processes. In this review, the effectiveness and advantage of complementary use of HPLC hyphenated techniques, LC-MS, LC-IR and LC-NMR, in the structure elucidation of pharmaceutical impurities are described.