氨磷汀HPLC测定方法的比较  

Comparison of HPLC Analysis of Amifostine

作　　者：祁飞飞[1] 廉明明[1] 孟庆伟[1] 李红梅 董述祥 

机构地区：[1]大连理工大学精细化工国家重点实验室 [2]大连美罗药业股份有限公司,辽宁大连116012

出　　处：《中国医药工业杂志》2009年第6期444-446,共3页Chinese Journal of Pharmaceuticals

摘　　要：比较了美国药典(USP31)和中国部颁标准中氨磷汀的HPLC测定法。美国药典采用不同比例的乙腈-水(含全氟丁基磺酸或三氟乙酸)作为流动相,中国部颁标准则采用甲醇-3.5mmol/L辛烷磺酸钠水溶液(磷酸调节pH3.0)为流动相。两法均用外标法测定氨磷汀含量。测定有关物质时,美国药典用外标法测定硫醇含量,归一法测其它有关物质;中国部颁标准则用自身对照法测定有关物质含量。The HPLC methods for determination Public Health Department were comparatively described. of amifostine, validated by USP 31 and China Ministry of Amifostine and its related substances were determined with the mobile phase of different rate of acetonitrile-water （containing nonafluorobutane sulfonic acid or trifluoroacetic acid） and methanol-3.5 mmol/L octanesulfonic acid sodium solution （pH 3.0）, respectively. The content of amifostine was determined by the external standard method for two methods. For USP 31, the content of thiol was determined by the external standard method and other related substances were determined by the normalization method. For China Department method, the related substances were determined by self contrast method.

关 键 词：氨磷汀 硫醇 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]