Evaluation of Chromatographic Methods for Drug Products Containing Polar and Non-Polar Molecules Using Reversed Phase, Hydrophilic Interaction, and Ion Exchange Chromatography

摘要: Abstract In recent years the pharmaceutical industry has developed an increasing variety of complex double or triple combination drug therapies. Method development for these products is particularly challenging when analytes have significantly different polarities, often requiring multiple chromatographic methods each active component. An alternative to commonly used practice developing reversed phase analyzing small molecules in discussed herein. Ion exchange chromatography offers many advantages other techniques analysis if one highly polar (log P < 0) and moderately non-polar (log P ≥ 0). As primary mode retention ion based upon charge molecule, hydrophobicity molecule does not play as large a part mechanism. long all molecule...