依达拉奉注射液中L-半胱氨酸盐酸盐的柱前衍生-HPLC法测定  

Determination of L-Cysteine Monohydrochloride in Edaravone Injection by HPLC with Pre-column Derivatization

作　　者：倪美萍[1] 卞玮[1] 陈英 杨亚妮[1] 何军[1] 

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201213 [2]国药集团新疆制药有限公司,新疆乌鲁木齐830032

出　　处：《中国医药工业杂志》2016年第6期780-782,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了柱前衍生-高效液相色谱法测定依达拉奉注射液中的L-半胱氨酸盐酸盐。以2,4-二硝基氯苯为柱前衍生化试剂,采用Diamonsil C18色谱柱,以乙腈∶0.01 mol/L磷酸氢二钠溶液（用磷酸调至p H 8.0）（40∶60）为流动相,检测波长360 nm。L-半胱氨酸盐酸盐在10-30μg/ml范围内线性关系良好。平均回收率为101.3%,RSD为0.6%。An HPLC method with pre-column derivatization was established for the determination of L-cysteine monohydrochloride in edaravone injection. 2,4-Dinitrochlorobenzene was used as the pre-column derivating agent. A Diamonsil C18 column was used, with the mobile phase of acetonitrile 0.01 mol/L disodium hydrogen phosphate solution （adjusted to pH 8.0 with phosphoric acid） （40 ： 60）, at the detection wavelength of 360 nm. It was linear for L-cysteine monohydrochloride in the range of 10-30 μg/ml. The average recovery was 101.3 %, with RSD of 0.6%.

关 键 词：依达拉奉注射液 L-半胱氨酸盐酸盐 柱前衍生化 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]