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
By: Giri, T
.
Contributor(s): Kukreja, Divya.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2023Edition: Vol.85(4), Jul-Aug.Description: 1068-1076p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: Method development for synthetic peptide molecules is often a challenging task as peptides get easily
degraded in mild stress conditions and also offer chromatographic challenges like carryover, peptide loss
during chromatographic run and adsorption of the drug onto the walls of the storage container. This article
presents an easy, accurate and reproducible stability-indicating, mass compatible Reverse Phase-Liquid
Chromatographic method for the detection of liraglutide in bulk active pharmaceutical ingredient. The stress
conditions chosen for the study (hydrolytic, oxidative, photolytic and thermal) were as per the International
Council for Harmonization guideline. Chromatographic separation of liraglutide from its degradation
products was achieved on a bioZen™ 2.6 μm Peptide XB-C18 100 Å, liquid chromatography column 150×4.6
mm, using ammonium formate buffer (pH 3.0) and acetonitrile (0.1 % formic acid) as the mobile phase in
gradient elution mode. The elution was carried out at a flow rate of 0.7 ml/min. Detection of liraglutide and its
degradants were monitored at 215 nm. Liraglutide was found to degrade significantly in hydrolytic, oxidative
and thermal stress conditions. Apart from stress testing, adsorption study for liraglutide was performed
using 5 different types of containers. Also, several buffers/diluents were screened to reduce the carryover of
active pharmaceutical ingredient in subsequent chromatographic runs.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2024-0416 |
Method development for synthetic peptide molecules is often a challenging task as peptides get easily
degraded in mild stress conditions and also offer chromatographic challenges like carryover, peptide loss
during chromatographic run and adsorption of the drug onto the walls of the storage container. This article
presents an easy, accurate and reproducible stability-indicating, mass compatible Reverse Phase-Liquid
Chromatographic method for the detection of liraglutide in bulk active pharmaceutical ingredient. The stress
conditions chosen for the study (hydrolytic, oxidative, photolytic and thermal) were as per the International
Council for Harmonization guideline. Chromatographic separation of liraglutide from its degradation
products was achieved on a bioZen™ 2.6 μm Peptide XB-C18 100 Å, liquid chromatography column 150×4.6
mm, using ammonium formate buffer (pH 3.0) and acetonitrile (0.1 % formic acid) as the mobile phase in
gradient elution mode. The elution was carried out at a flow rate of 0.7 ml/min. Detection of liraglutide and its
degradants were monitored at 215 nm. Liraglutide was found to degrade significantly in hydrolytic, oxidative
and thermal stress conditions. Apart from stress testing, adsorption study for liraglutide was performed
using 5 different types of containers. Also, several buffers/diluents were screened to reduce the carryover of
active pharmaceutical ingredient in subsequent chromatographic runs.
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