Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy

V. I. Krylov; A. A. Kutin; V. A. Yashkir; V. A. Merkulov; N. E. Kuz’mina; S. V. Moiseev

doi:10.1007/s11094-017-1587-2

Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy

Authors: Krylov V.I.¹, Kutin A.A.¹, Yashkir V.A.¹, Merkulov V.A.¹, Kuz’mina N.E.¹, Moiseev S.V.¹
Affiliations:
1. National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Issue: Vol 51, No 3 (2017)
Pages: 226-229
Section: Article
URL: https://ogarev-online.ru/0091-150X/article/view/244543
DOI: https://doi.org/10.1007/s11094-017-1587-2
ID: 244543

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Abstract

The acid hydrolysis procedure for glatiramer acetate was modified and the characteristic signals in the ¹H and ¹³C spectra were identified, allowing its amino acid composition to be determined. The relative molar contents of amino acids in glatiramer acetate measured by HPLC-MS and by ¹³C and ¹H NMR had close values. ¹³C NMR was found to be a more precise method for assaying the amino acid composition of glatiramer acetate than ¹H NMR.

Keywords

glatiramer acetate, amino acid composition, acid hydrolysis, NMR spectroscopy