HPLC法测定丁二磺酸腺苷蛋氨酸肠溶片中3种有关物质  

Determination of three related substances in adenosine methionine succinate enteric-coated tablets by HPLC

作　　者：刘晓敏[1] 刘广洲[1] 姚欣欣[1] 王维纲[1] 兰汝春[1] 张春华[1] LIU Xiaomin;LIU Guangzhou;YAO Xinxin;WANG Weigang;LAN Ruchun;ZHANG Chunhua(The Affiliated Hospital of Jilin Medical College,Jilin 132013,China)

机构地区：[1]吉林医药学院附属医院,吉林吉林132013

出　　处：《沈阳药科大学学报》2021年第9期910-915,共6页Journal of Shenyang Pharmaceutical University

基　　金：吉林省中医药管理局项目(2017248)。

摘　　要：目的采用高效液相色谱法测定丁二磺酸腺苷蛋氨酸肠溶片中的有关物质。方法色谱柱为Agilent ZORBAX SB-C18(250 mm×4.6 mm, 5μm)柱;流动相为4 mmol·L^(-1)辛烷磺酸钠溶液(含0.1 mol·L^(-1)甲酸铵和体积分数0.04%三乙胺,甲酸调节pH至2.6)-甲醇(体积比8∶2);检测波长为260 nm;柱温30℃;进样体积10μL。结果主成分腺苷蛋氨酸与腺嘌呤、S-腺苷-L-高半胱氨酸、甲硫腺苷3种杂质完全分离,分离度均大于1.5。杂质腺嘌呤、S-腺苷-L-高半胱氨酸和甲硫腺苷的质量浓度分别在0.102 0~10.17 mg·L^(-1)、0.102 2~10.23 mg·L^(-1)和0.404 1~40.35 mg·L^(-1)内与峰面积呈良好的线性,r>0.999。回收率分别为99.5%、100.3%和100.2%。结论该方法适用于丁二磺酸腺苷蛋氨酸肠溶片中有关物质的控制。Objective To determine the related substances in adenosine methionine succinate enteric-coated tablets by high performance liquid chromatography.Methods The chromatography column was Agilent ZORBAX SB-C18(250 mm×4.6 mm, 5 μm);the mobile phase was a 0.05% sodium octane sulfonate solution containing 0.1 mol·L^(-1) ammonium formate(containing 0.04% triethylamine, formic acid to adjust the pH to 2.6)-methanol(V∶V= 8∶2);using an ultraviolet detector, the wavelength was 260 nm.Results The main components adenosine methionine can be effectively separated from adenine, S-adenosyl-L-homocysteine, and methylthioadenosine, the resolution was greater than 1.5.The concentrations of impurities adenine, S-adenosyl-L-homocysteine, and methylthioadenosine in the range of 0.102 0-10.17 mg·L^(-1),0.102 2-10.23 mg·L^(-1) and 0.404 1-40.35 mg·L^(-1),it was well linear with the peak area.Conclusion This method is accurate, rapid, and highly sensitive.It is suitable for the control of related substances in adenosylmethionine succinate enteric-coated tablets.

关 键 词：高效液相色谱法 丁二磺酸腺苷蛋氨酸肠溶片 有关物质 

分 类 号：R917[医药卫生—药物分析学]