title: High-performance liquid chromatography/tandem mass spectrometry identification of salmon calcitonin degradation products in aqueous solution preparations.
abstract: Degradation impurities have been investigated, by means of high-performance liquid chromatography (HPLC)/ mass spectrometry, in commercial ampoules of salmon calcitonin, aqueous solution, stored for up to 2 years. Oxidation derivatives of the cysteine residues in positions 1 and 7, with cleavage of the disulfide bridge, were observed in all samples. Using our reversed-phase separation, these oxidation derivatives coeluted and presented an HPLC behavior identical to the derivative of salmon calcitonin with the disulfide bridge reduced. In a previous study this last compound was tentatively identified, without confirmation by mass spectrometry, as a major degradation product of salmon calcitonin in aqueous solution.
authors.affiliation: Res Pharma Pharmacological Research S.r.1, Torino, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Silvestro
authors.forename: S R
authors.initials: SR
authors.lastname: Savu
mesh_terms: D000595:Amino Acid Sequence; D002116:Calcitonin / Q000032:analysis* / Q000737:chemistry; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006868:Hydrolysis; D013058:Mass Spectrometry; D008969:Molecular Sequence Data; D012996:Solutions; D014357:Trypsin
chemical_list: D012996:Solutions; C028815:salmon calcitonin; D002116:Calcitonin; D014357:Trypsin