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US 10,539,568 B2Granted
RP-HPLC analysis of complex polypeptide mixtures
AssigneeChemi S.p.A.
InventorsMaria Lattanzio, Aureliano Gaiassi, Andrea Stevenazzi
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Abstract
The present invention relates to reversed phase high-performance liquid chromatography (HPLC) methods useful for the characterisation of glatiramer acetate or similar polypeptide mixtures. The method described herein can distinguish glatiramer acetate from non-conforming copolymers and may be used to choose batches of glatiramer acetate suitable for pharmaceutical use.
Claims13
A method for analyzing a mixture of polypeptides, said method comprising the following steps,
- a) subjecting said mixture of polypeptides to analytical reversed-phase high-performance liquid chromatography, with a mobile phase comprising a mixture of at least two solutions having different polarity, a more polar solution and a less polar solution, wherein the less polar solution has a volume percentage that increases over time in a stepwise manner;
- and
- b) recording a chromatogram on a chromatographic system equipped with a suitable detector,
- wherein said mixture of polypeptides contains four specific amino acids:
- L-glutamic acid, L-alanine, L-tyrosine and L-lysine, in defined molar fraction ranges.
2 more elements
Dependencies are inferred from the claim text.