Structurally related peptide impurity identification and accurate quantification for synthetic oxytocin by liquid chromatography–high-resolution mass spectrometry
| Autor: | Adeline Daireaux, Tiphaine Choteau, Steven Westwood, Hongmei Li, Ralf D. Josephs, Robert Wielgosz, Ming Li, Gustavo Martos |
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| Rok vydání: | 2021 |
| Předmět: |
chemistry.chemical_classification
Analyte Chromatography Chemistry 010401 analytical chemistry Peptide 02 engineering and technology 021001 nanoscience & nanotechnology Mass spectrometry 01 natural sciences Biochemistry 0104 chemical sciences Analytical Chemistry Oxytocin Impurity Potential biomarkers medicine Value assignment 0210 nano-technology Related impurities hormones hormone substitutes and hormone antagonists medicine.drug |
| Zdroj: | Analytical and Bioanalytical Chemistry. 413:1861-1870 |
| ISSN: | 1618-2650 1618-2642 |
| Popis: | Oxytocin (OXT) is an important peptide that is mainly used as a therapeutic drug to induce labor or strengthen uterine contractions, or to control bleeding after childbirth. OXT has also been reported as a biomarker linked to emotion, and as a potential biomarker for cancer diagnosis. The accurate purity characterization of OXT calibrators is critical for quality control of pharmaceuticals and the development of reference measurement systems for this analyte in laboratory medicine. OXT possesses the particular analytical measurement challenge of a disulfide bond. Accurate value assignment of the purity of oxytocin calibrators can be carried out by applying the mass balance approach or alternative approaches such as amino acid analysis, quantitative nuclear magnetic resonance spectrometry, and nitrogen determination. In order to avoid biases, all these approaches require a correction for structurally related peptide impurities. Structurally related peptide impurities present in a synthetic OXT material have been identified and quantified by a newly developed and in-house-validated liquid chromatography–high-resolution mass spectrometry (LC-hrMS) method. This method was adopted for the measurement of the study material used for an international comparison evaluating the competencies of laboratories to perform peptide characterization. Eighteen structurally related impurities were identified, confirmed, and accurately quantified in the OXT study material by using LC-hrMS. The study material contained a total mass fraction of 31.1 mg/g structurally related OXT impurities with an associated expanded uncertainty of 1.7 mg/g. |
| Databáze: | OpenAIRE |
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