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 Chi-nese Pharmacopoeia(Ch.P).CONCLUSION The method is simple,accurate and stable.It can control the impurities in somatosta-tin for injection and provide a basis for improving the standard of this drug.
关键词
注射用生长抑素/高效液相色谱法/有关物质/方法学验证/方法比较
Key words
somatostatin for injection/high performance liquid chromatography/related substance/method verification/method comparison
维普
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