盐酸诺拉曲塞及其有关物质的HPLC法测定  

Determination of Nolatrexed Dihydrochloride and Its Related Substances by HPLC

作　　者：周一萌[1] 张庆文[1] 周斌[1] 

机构地区：[1]中国医药工业研究总院上海医药工业研究院,上海201203

出　　处：《中国医药工业杂志》2015年第11期1217-1219,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定诺拉曲塞及其有关物质。使用TSK-C18色谱柱,流动相为0.02 mol/L磷酸二氢钾溶液（用氢氧化钠溶液调至p H 6.5）∶甲醇（48∶52）,检测波长226 nm。诺拉曲塞与有关物质分离完全。盐酸诺拉曲塞二水合物在0.005~0.5 mg/ml范围内线性关系良好,平均回收率为100.3%,RSD为0.13%。An HPLC method was established for the determination of nolatrexed and its related substances. A TSK-C18 column was used with the mobile phase of 0.02 mol/L potassium dihydrogen phosphate solution （adjusted to pH 6.5 with sodium hydroxide solution） ; methanol （48 ： 52） at the detection wavelength of 226 nm. Nolatrexed and its related substances were separated well. It was linear in the concentration range of 0.005 - 0.5 mg/ml for nolatrexed dihydrochloride dihydrate. Its average recovery was 100.3 %, with RSD of 0.13 %.

关 键 词：诺拉曲塞 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]