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To establish a liquid-liquid extraction method for the determination of genotoxic impurities N-nitrosodimethylamine（NDMA） and N-nitrosodiethylamine（NDEA） in chondroitin sulfate sodium by gas chromatography-mass spectrometry (GC-MS).
The chromatographic column was Thermo TG WAXMS (30 m × 0.25 mm，0.25 μm）. The column temperature was maintained at 40 ℃ for 1 min，increased to 240 ℃ at 25 ℃·min-1 and maintained for 2 min. The inlet temperature was 220 ℃. The carrier gas was high-purity helium，and the flow rate was 1.0 mL·min-1. The ion source of mass spectrometry was EI source. The electron energy was 70 eV. The ion source temperature was 280 ℃ and the transmission line temperature was 240 ℃. Injection volume was 1 μL.
The LOD of NDMA was 0.64 ng·mL-1. Experiment showed a good linear relationship between peak area and concentration in the range of 4-16 ng·mL-1，and the correlation r was 0.999 3. The LOD of NDEA was 0.176 ng·mL-1 with a good linear relationship between peak area and concentration within the range of 1.1-4.4 ng·mL-1. The correlation r was 0.999 6. NDMA and NDEA were not detected in chondroitin sulfate sodium.
The method is simple，specific and can be used to determine the genotoxic impurities NDMA and NDEA in chondroitin sulfate sodium.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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