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- W3006540880 abstract "Rationale Glatiramer acetate (GA) (Copaxone®) is a non‐biological complex drug (NBCD) comprising random‐sequence polymer chains of four amino acids (MW ~ 5–9 kDa) with unknown structure. The characterization of NBCDs by reversed‐phase liquid chromatography/mass spectrometry (RPLC/MS) peptide mapping is often impeded by insufficient separation and/or low sensitivity. To overcome this issue, pre‐column derivatization of GA peptide digest was used to improve RPLC/MS detectability and to generate a comprehensive peptide profile. Methods Amino groups of peptides generated by trypsin digestion of GA were derivatized using 6‐aminoquinolyl‐ N ‐hydroxysuccinimidyl carbamate (AQC) reagent. The derivatized mixture of random‐sequence peptides was analyzed by liquid chromatography/positive‐mode electrospray ionization collision‐induced dissociation high‐resolution mass spectrometry (RPLC/ESI‐CID‐HRMS/MS). Data‐independent LC/MS E mode was used for data acquisition. Results The derivatization of the GA peptide mixture increased the detectability of RPLC/ESI‐CID‐HRMS/MS analysis. The efficacy of the procedure was demonstrated by using selected peptides related to different polymeric chain origins. The resultant peptides were derivatized in a predictable manner giving a minimum of side products. The reproducibility of the developed method was demonstrated by comparing peptide elution profiles derived from six Copaxone® lots. Conclusions Application of the AQC pre‐column derivatization provides a framework that could be used as an attractive approach for monitoring the quality and characterization of NBCD products in the pharmaceutical industry." @default.
- W3006540880 created "2020-02-24" @default.
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- W3006540880 date "2020-03-20" @default.
- W3006540880 modified "2023-09-26" @default.
- W3006540880 title "Application of 6‐aminoquinolyl‐ <i>N</i> ‐hydroxysuccinimidyl carbamate derivatization for enhanced peptide mapping analysis of non‐biological complex drug glatiramer acetate using liquid chromatography/electrospray ionization collision‐induced dissociation high‐resolution mass spectrometry" @default.
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- W3006540880 doi "https://doi.org/10.1002/rcm.8748" @default.
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