RT Journal Article
T1 Method for identification and quantification of intact teduglutide peptide using (RP)UHPLC-UV-(HESI/ORBITRAP)MS.
A1 Perez-Robles, Raquel
A1 Salmeron-Garcia, Antonio
A1 Clemente-Bautista, Susana
A1 Jimenez-Lozano, Ines
A1 Cabañas-Poy, Maria Josep
A1 Cabeza, Jose
A1 Navas, Natalia
K1 Humans
K1 Chromatography, High Pressure Liquid
K1 Short Bowel Syndrome
K1 Glucagon-Like Peptide 2
K1 Peptides
AB Teduglutide (Revestive®, 10 mg mL-1) is a recombinant human glucagon-like peptide 2 analogue, used in the treatment of short bowel syndrome, a serious and highly disabling condition which results from either too small a length of intestine or loss of critical intestinal function. The determination of therapeutic compounds of protein-nature is always challenging due to their complex structure. In this work, we present a fast, straightforward reversed phase (RP)UHPLC-UV-(HESI/ORBITRAP)MS method for the identification and quantification of the intact teduglutide peptide. The method has been developed and validated in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines; therefore, linearity, limits of detection and quantification, accuracy (precision and trueness), robustness, system suitability and specificity using the signal from the UV and MS, have been evaluated. The validation performance parameters obtained from the UV and MS signals were compared throughout the work, to select the most suitable. To study the specificity of the method and the impact of medicine mishandling under hospital conditions, force degradation studies were performed, i.e. thermal (40 °C and 60 °C), shaking (mechanical) and light (accelerated exposition) effects. Identification by the exact mass of teduglutide was achieved and it was confirmed that the peptide does not undergo any post-translational modifications (PTMs). To the best of our knowledge, the present work reports the first method developed for the simultaneous identification, structural characterization, and quantification of the therapeutic teduglutide peptide. Finally, the proposed method is able to indicate stability when quantifying the intact teduglutide since detects and characterises the exact mass of the degradation/modification products.
PB Royal Society of Chemistry
YR 2022
FD 2022-10-09
LK http://hdl.handle.net/10668/19643
UL http://hdl.handle.net/10668/19643
LA en
NO Pérez-Robles R, Salmerón-García A, Clemente-Bautista S, Jiménez-Lozano I, Cabañas-Poy MJ, Cabeza J, et al. Method for identification and quantification of intact teduglutide peptide using (RP)UHPLC-UV-(HESI/ORBITRAP)MS. Anal Methods. 2022 Nov 10;14(43):4359-4369.
DS RISalud
RD Apr 19, 2025