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OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for the detection of related substances in somatostatin for injection. METHODS The determination was performed on a C18 column with mobile phases consisting of potassium dihydrogen phosphate solution and acetonitrile by gradient elution. The detection wavelength was set at 215 nm and the column temperature was maintained at 50 ℃. RESULTS The established method can effectively separate the main components and seven major degradation impurities. The peak area of somatostatin and 7 kinds of impurities had good linear relationships with the concentration (r≥0.999 1, n=8). Relative standard deviation (RSD) of precision, stability and repeatability tests of 7 kinds of impurities were all lower than 3.6%. The average recoveries of 7 kinds of impurities ranged from 100.0% to 104.4% (n=9). The impurity content determined by the established method is higher than that determined by the European Pharmacopoeia(EP) and Chinese Pharmacopoeia(Ch.P). CONCLUSION The method is simple, accurate and stable. It can control the impurities in somatostatin for injection and provide a basis for improving the standard of this drug.
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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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