反相高效液相色谱法测定注射用腺苷蛋氨酸的含量  

RP-HPLC determination of ademetionine for injection

作　　者：赵鹏[1] 王东凯[1] 崔亚男[1] 苏娟娟[2] 仲静洁[1] 王宇 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]沈阳沃森药物研究所,沈阳110016 [3]辽宁电力中心医院,沈阳110016

出　　处：《中国新药杂志》2006年第12期992-994,共3页Chinese Journal of New Drugs

摘　　要：目的:建立注射用腺苷蛋氨酸制剂中腺苷蛋氨酸含量测定的方法。方法:采用Diamonsil^(TM)(钻石) C_(18)ODS柱(250 mm×4．6 mm,5μm);流动相为甲酸铵6．3 g,辛烷磺酸钠1．0 g,加水700 mL溶解,用甲酸调节pH值至3．8,加水稀释至1000 mL,取此溶液660 mL加甲醇340 mL,混匀,即得;流速为0．9 mL·min^(-1),紫外检测波长为260 nm,柱温为30℃。结果:在本色谱条件下腺苷蛋氨酸与辅料、溶剂峰及其有关物质的分离度符合要求,在200～600μg·mL^(-1)范围内线性良好(r=0．9998)。回收率为99．61%～99．98%,RSD为0．23%～1．3%。结论:测定方法简便、准确,灵敏度高,方法可靠,可作为该制剂的质量控制方法。Objective： To establish a RP-HPLC Methods： The RP-HPLC analysis was performed with 4. 6 mm, 5μm） at 30℃ and detective wavelength at 260 method for the a Diamonsil^TM determination of ademetionine. Cl80DS column （250 mm×nm. The eluate was prepared by dissolving ammonium formate 6.3 g and octanen sulfoacid sodium 1.0 g in 700 mL water （ pH 3.8 adjusted with formic acid） and subsequently diluted with water to 1 000 mL. The mobile solution was consisted of the solution and methanol （66： 34） with flow rate of 0. 9 mL. min^-l Results： The calibrated linear curve of ademe- tionine concentration was in the range of 200 600μg. mL^- l （ r = 0. 999 8 ）. The average recovery rate was 99.61%-99. 98% with RSD of 0. 23%-1.3%. Conclusion： This sensitive and reliable RPHPLC method is used for the quality control of ademetionien for injection.

关 键 词：腺苷蛋氨酸 反相高效液相色谱法 含量测定 

分 类 号：R917.4[医药卫生—药物分析学] R977.4[医药卫生—药学]