谢升谷,孙逍,陈悦.HPLC法测定注射用丁二磺酸腺苷蛋氨酸中腺苷蛋氨酸含量[J].中国药品标准,2019,20(4):346-349 |
HPLC法测定注射用丁二磺酸腺苷蛋氨酸中腺苷蛋氨酸含量 |
HPLC method for analysis of ademetionine in Ademetionine Butanedisulfonate for Injection |
投稿时间:2018-12-19 修订日期:2019-06-25 |
DOI: |
中文关键词: 注射用丁二磺酸腺苷蛋氨酸 腺苷蛋氨酸 HPLC |
英文关键词: Ademetionine Butanedisulfonate for Injection ademetionine HPLC |
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中文摘要: |
目的:建立HPLC法测定注射用丁二磺酸腺苷蛋氨酸中腺苷蛋氨酸的含量。 方法:采用Waters Sunfire C18色谱柱,以乙腈和含0.2mol/L甲酸铵的0.1%辛烷磺酸钠溶液(用甲酸调节pH值至2.8)(10:90)为流动相,柱温30°C,流速1.5 ml?min-1,检测波长为260nm。 结果:腺苷蛋氨酸峰与样品中其它杂质峰的分离度良好,样品中的腺苷蛋氨酸含量为98.4%~99.0%。 结论:本方法简便、准确性好、灵敏度高,可以有效地测定注射用丁二磺酸腺苷蛋氨酸中腺苷蛋氨酸的含量。 |
英文摘要: |
Objective: To establish a HPLC method for determination of ademetionine in Ademetionine Butanedisulfonate for Injection. Method:The determination was performed on a Waters Sunfire C18 column, with a mobile phase consisting of mixture of Acetonitrile/buffer solution (dissolve 12.6g ammonium formate in 1000ml of 0.1% octane sulfonic acid sodium solution, adjusted with formic acid to a pH value of 2.8) (10:90). The column temperature was set at 30°C with a flow rate of 1.5 ml.min-1. The detection wavelength was 260nm. RESULTS:The resolution of ademetionine and other impurities was good. Content of ademetionine in samples was from 98.4% to 99.0%. Conclusion:The method is convenient, accurate and sensitive to be used for determination of content of ademetionine in Ademetionine Butanedisulfonate for Injection. |
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