LAUSR

As per United States Food and Drug Administration, any polymer/chain composed of 40 or fewer amino acids is called as a peptide, where more than 40 amino acids are considered as proteins. In many occasions there is a change in the source of manufacturing of the peptide active pharmaceutical ingredient, where one has to prove the sameness of that product with the existing formulation by considering several aspects like presence of impurities/degradation products, extent of aggregations etc. For the same, several chromatographic characterization techniques such as; Reverse phase high performance liquid chromatography-ultraviolet/high resolution mass spectrometry, supercritical fluid chromatography, size exclusion chromatography, Ion exchange chromatography etc are widely used in pharmaceutical industry. It is well known that the method development of peptide molecules is often challenging as many variables are to be kept in mind which can affect the separation, recovery and stability of molecule. The present review focuses on the basics of peptide degradation and method development by using various chromatographic techniques for characterization. It also covers a deep insight of method development parameters and variables to be considered which might directly or indirectly affect the chromatographic separation and recovery, and also provides a guide on selection of chromatographic parameters. This article is protected by copyright. All rights reserved.