Synthetic pharmaceutical peptides characterization by chromatography principles and method development

Abstract

As per the United States Food and Drug Administration, any polymer/chain composed of 40 or fewer amino acids is called a peptide, where more than 40 amino acids are considered proteins. On 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 the presence of impurities/degradation products, the extent of aggregations, and so forth. For the same, several chromatographic characterization techniques such as reversed-phase high-performance liquid chromatography-ultraviolet/high-resolution mass spectrometry, supercritical fluid chromatography, size-exclusion chromatography, ion-exchange chromatography, and so forth, are widely used in the 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 the 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 the selection of chromatographic parameters.

Preparation of carboxyl‐functionalized silica core‐shell microspheres and their applications in weak cation exchange chromatography, heavy metal removal, and lysozyme enrichment

“…Among these materials, the core‐shell structure was first proposed by Horvath [18] and Kirkland [19] in the 1969s. However, due to the rapid development of fully porous microspheres at that time, many researchers did not pay attention to core‐shell microspheres in ion exchange chromatography, commonly used ion exchange matrices include agarose, polystyrene, polyacrylamide, cellulose, and polymethacrylate [20]. Until 2007, the emergence of commercial core‐shell materials, especially silica core particles, truly enters people's field of vision [21].…”

Capillary electrophoresis in the analysis of therapeutic peptides—A review

“…Currently, the most prevalent analytical methods in the analysis of therapeutic peptides are based on LC hyphenated with ultraviolet (UV) and MS detection, size exclusion chromatography (SEC), and so on [19,20]. Capillary electrophoresis (CE) methods are valued as counterparts and complement LC methods, capable of gathering additional analytical information about pharmaceutical products and analyzing being more cost-effective [21,22].…”

Establishment of Stability-Indicating Purity Method Based on the Stress Degradation Behaviour of Human Glucagon-like Peptide-1 Analog Liraglutide using Reverse Phase-Liquid Chromatography

“…The overall degradation pattern of protein/peptide depends on the sequence of amino acids and other functional groups. Stress testing of peptides are generally initiated from milder conditions as compared to small molecules because peptides are more sensitive to environmental stress like hydrolytic oxidative, thermal stress etc [7,8] .…”