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目的用HPLC法测定丁二磺酸腺苷蛋氨酸原料及制剂中的有关物质。方法采用KromstarTMC18色谱柱(250 mm×4.6 mm,5μm),流动相为含0.1 moL·L-1甲酸铵的0.05%辛烷磺酸钠溶液(甲酸调pH4)-甲醇-乙腈(74.5∶25∶0.5),检测波长260 nm,柱温35℃,流速0.8 mL·min-1。结果丁二磺酸腺苷蛋氨酸峰与各杂质峰均能良好分离;S-腺苷-L-高半胱氨酸、腺嘌呤、丁二磺酸腺苷蛋氨酸、甲硫腺苷分别在0.073～19.380、0.028～22.157、0.130～20.920、0.101～80.360μg·mL-1与峰面积呈良好的线性关系。S-腺苷-L-高半胱氨酸、腺嘌呤、甲硫腺苷的平均回收率分别为103.2%、99.5%、101.3%,RSD分别为1.97%、1.26%、1.83%(n=12)。结论所用方法灵敏、准确,专属性强,可同时测定丁二磺酸腺苷蛋氨酸原料和制剂中的有关物质。
Objective To determine the related substances in adenosine methionine succinate and its preparation by HPLC method. Methods Kromstar TMC18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.05% sodium octane sulfonate solution containing 0.1 mol·L-1 ammonium formate (adjusted to pH 4) -methanol-acetonitrile 0.5). The detection wavelength was 260 nm. The column temperature was 35 ℃ and the flow rate was 0.8 mL · min-1. Results Both adenosine methionine and disulfide adenine methionine peaks were well separated from each other. S-adenosyl-L-homocysteine, adenine, adenosine methionate, 19.380,0.028 ~ 22.157,0.130 ~ 20.920,0.101 ~ 80.360μg · mL-1 and the peak area showed a good linear relationship. The average recoveries of S-adenosyl-L-homocysteine, adenine and methylthioadenosine were 103.2%, 99.5% and 101.3%, respectively, with RSDs of 1.97%, 1.26% and 1.83% ). Conclusion The method used is sensitive, accurate and specific. It can be used for simultaneous determination of adenosine methionine and its related substances.