Structure identification of primary degradation impurities in domestic calcitonin salmon injections by LC-MS
- Author:
Xue REN
1
Author Information
- Publication Type:Journal Article
- Keywords: Calcitonin C; Calcitonin salmon injection; Degradation impurity; Dehydro-ala-calcitonin dimer; LC-MS; Structure indentification; Trisulfur salmon calcitonin
- From: Chinese Pharmaceutical Journal 2015;50(2):174-177
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To establish an LC-MS method for identification of the primary degradation impurities in domestic calcitonin salmon injections. METHODS: For the RPLC analysis., the separation was performed on Waters XTerra RP C18 column (3.0 mm × 50 mm, 3.5 μm) with linear gradient elution using 0.05% aqueous trifluoroacetic acid (A) and acetonitrile (B); the flow rate was 0.5 mL · min-1; the column temperature was 40℃; the detection wavelength was set at 220 nm. For the SEC analysis, the separation was performed on TSK GEL 2000SWxl column (7.8 mm × 300 mm, 5 μm) with mobile phase consisting of TFA-water-acetonitrile(0.05:80:20); the flow rate was 0.7 mL · min-1; the column temperature was room temperature; the detection wavelength was set at 220 nm; the main impurities were collected and identified by positive mode. RESULTS: The structures of three impurities were elucidated by RPLC-MS and SEC-MS. CONCLUSION: The results of this study can be applied in impurity profile analysis, specification research, and quality control of calcitonin salmon injections.
