Full
Outline
To establish an HPLC-CAD method for determination of mannitol in somatostatin for injection.
Mannitol was determined by HPLC-CAD with Agilent 300Extend-C18 column (250 mm×4.6 mm, 5 μm), the mobile phase was acetonitrile-water (15∶85) at the flow rate of 1.0 mL·min-1, the column temperature was 35 ℃, and the injection volume was 20 μL. Charged aerosol detector (CAD) was used as detector, the evaporate tube temperature was 50 ℃, nebulizer gas was nitrogen, the flow pressure was about 60 psi, and the gain value was 1.
The detection limit for mannitol was 1.004 μg·mL-1, and the limit of quantitation was 3.012 μg·mL-1. The quadratic curves showed good linearity in the range of 0.1~1.0 mg·mL-1(r2=0.999 8). The average recovery was 99.1% (RSD=0.60%).
This method is simple, rapid, sensitive, accurate and suitable for the quality control of mannitol in somatostatin for injection.
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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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