HPLC Impurity Profile Analyses of Pharmaceutical Substances Using UV Photodiode Array DEtection

Abstract

High performance liquid chromatography (HPLC) is routinely used for determination of both assay and impurities in both bulk active and formulated drug products. Impurity profile analyses are required to demonstrate the ability to detect a wide range of impurities which may occur in pharmaceuticals. However, most impurity profile methods do not address the potential of co-elution of impurities with product peaks. UV photodiode array detection (PDA) evaluates the UV and/or the UV/VIS spectrum of an eluting species to determine spectral homogeneity. If variations in the spectrum are observed, the possibility of a co-eluting impurity must be addressed. By establishing consistent evaluations HPLC-PDA can be used to more accurately assess impurity levels and provide analyses with much higher informational content.

Key Words:

• Impurity
• HPLC
• UV Photodiode Array
• Spectral Homogeneity
• Coelution.