TY - JOUR
T1 - Identity Profiling of Complex Mixtures of Peptide Products by Structural and Mass Mobility Orthogonal Analysis
AU - Vázquez-Leyva, Said
AU - Vallejo-Castillo, Luis
AU - López-Morales, Carlos A.
AU - Herbert-Pucheta, José Enrique
AU - Zepeda-Vallejo, L. Gerardo
AU - Velasco-Velázquez, Marco
AU - Pavón, Lenin
AU - Pérez-Tapia, Sonia M.
AU - Medina-Rivero, Emilio
N1 - Publisher Copyright:
© 2019 American Chemical Society.
PY - 2019
Y1 - 2019
N2 - Identity is a critical quality attribute that must be determined before releasing batches of medicinal and dietary products. However, the identities of peptide-derived products composed of a large number of diverse molecules is challenging since most analytical techniques cannot analyze multiple molecules simultaneously. Here, we proposed the determination of the weight-average molecular weight (Mw) and polydispersity index (PDI) by mass spectrometry for control quality for the batch release of complex products, namely, glatiramer acetate (Copaxone), collagen hydrolysate (Colagenart), and a human dialyzable leucocyte extract (Transferon). The Mw and PDI values were orthogonally determined by PFG-STE-H2O(presaturation)-DOSY-NMR analysis. To the best of our knowledge, this is the first time that MS and NMR spectra have been combined to determine the PDI of complex products derived from protein hydrolysis that are not monodisperse. The performance of each method was evaluated by comparing the obtained results to those reported for glatiramer acetate using MALLS, the technique commonly employed to determine PDI. This combined approach demonstrates the ability of these techniques to separate peptide populations from complex mixtures to establish their identity through their mass distribution profiles.
AB - Identity is a critical quality attribute that must be determined before releasing batches of medicinal and dietary products. However, the identities of peptide-derived products composed of a large number of diverse molecules is challenging since most analytical techniques cannot analyze multiple molecules simultaneously. Here, we proposed the determination of the weight-average molecular weight (Mw) and polydispersity index (PDI) by mass spectrometry for control quality for the batch release of complex products, namely, glatiramer acetate (Copaxone), collagen hydrolysate (Colagenart), and a human dialyzable leucocyte extract (Transferon). The Mw and PDI values were orthogonally determined by PFG-STE-H2O(presaturation)-DOSY-NMR analysis. To the best of our knowledge, this is the first time that MS and NMR spectra have been combined to determine the PDI of complex products derived from protein hydrolysis that are not monodisperse. The performance of each method was evaluated by comparing the obtained results to those reported for glatiramer acetate using MALLS, the technique commonly employed to determine PDI. This combined approach demonstrates the ability of these techniques to separate peptide populations from complex mixtures to establish their identity through their mass distribution profiles.
UR - http://www.scopus.com/inward/record.url?scp=85074880993&partnerID=8YFLogxK
U2 - 10.1021/acs.analchem.9b02873
DO - 10.1021/acs.analchem.9b02873
M3 - Artículo
C2 - 31664820
AN - SCOPUS:85074880993
SN - 0003-2700
JO - Analytical Chemistry
JF - Analytical Chemistry
ER -