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Altura Poroshell HILIC-Z Ultra Inert Chromatography Column Helps with Prescription Analysis of GLP-1 Formulations
Date: 2025-11-12Read: 0
In view of the increasing global incidence rate of type 2 diabetes and obesity, the demand for synthetic peptides targeting GLP-1 and other incretin receptors is also increasing, and the analytical method for evaluating drug quality is also important. Reverse phase liquid chromatography, volume exclusion chromatography, and mass spectrometry are commonly used for various properties such as impurities in active drugs. This study used hydrophilic interaction liquid chromatography (HILIC) as a supplementary method, combined with diode array (DAD) and evaporative light scattering detection (ELSD), to simultaneously determine therapeutic peptides and excipients (inorganic ions, sugars, etc.) in drugs (DP).
To avoid non-specific interactions between metal sensitive components and metal flow paths, low adsorption biocompatible liquid-phase hardware is used:Agilent Altura Poroshell HILIC-Z Column (Ultra Inert Technology)+Agilent 1290 Infinity III Bioliquid Chromatography System.
Experimental Section
material
preprocessing
Simeglutide and Liraglutide were dissolved in DMSO at a concentration of 1 mg/mL and heated to dissolve. Exenatide and Tilpotide were dissolved in 50/50 (v/v) acetonitrile/water at a concentration of 1 mg/mL. Dilute further with water before injection. Byetta, Ozempic, and Xultophy were directly injected into the chromatographic column for analysis. Auxiliary solution (glycerol, mannitol, sucrose, NaCl, NaH)2PO4Both zinc acetate and zinc acetate were prepared using water. Incubate exenatide with 0.004% hydrogen peroxide at room temperature for 3 hours to induce methionine oxidation. Quench the reaction by adding 1 mM L-methionine.
Instruments and chromatography columns
Experimental Results and Discussion
The Altura Poroshell HILIC-Z chromatographic column, equipped with a biologically inert tubing configuration and utilizing ultra-high performance technology, has demonstrated significant advantages in the prescription analysis of GLP-1 receptor agonist formulations.
HILIC technology can effectively retain/separate polar/ionic solutes (such as sugars, salts, peptides, etc.). The Altura HILIC-Z column is adapted to the Agilent 1290 Infinity III bio liquid phase system, successfully achieving the separation of excipients (glycerol, mannitol), ions (Na ⁺, Cl ⁻, PO ₄³ ⁻), and peptides (exenatide, liraglutide, etc.) in GLP-1 drugs.
When using tandem DAD and ELSD detection, the Altura Poroshell HILIC-Z column can simultaneously analyze active ingredients, excipients, impurities, and even saturated concentrations of excipients (such as 43 mg/mL mannitol) in drugs.
Improvement of peak shape: In the inert flow path, the tailing factor of the peaks of tilpotide and semaglutide is significantly reduced, and the peak shape is more symmetrical; The impurities in the main peak trailing part of the stainless steel flow path are easily masked.
Recovery rate improvement: The recovery rate of active ingredients is close to 100%, while stainless steel has a loss in recovery rate.
Impurity detection is more sensitive: it can detect masked impurities in low adsorption pipelines (such as the isomers of exenatide after H ₂ O ₂ oxidation), and can observe the separation of enantiomers of methionine sulfoxide.
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