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.pdfVIP

• 780 • 中国医药工业杂志 Chinese Journal of Pharmaceuticals 2016 , 47 (6) 依达拉奉注射液中L半肮氨酸盐酸盐的柱前衍生 -HPLC 法测定 倪美萍1 ，卡琦l ，陈英2 ，杨亚妮l* ，何军l (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) 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- 半脱氨酸盐酸盐。以 2 ， 4- 二硝基氯苯为柱前衍生化 试剂，采用 Diamonsil C 色谱柱，以乙腊 0.01 mol/L磷酸氢二纳溶液(用磷酸调至 pH 8.0) (40 : 60) 为流动相，检测 18 波长 360 nm. L- 半脱氨酸盐酸盐在 10 ~ 30 Jlglml 范围内线性关系良好。平均回收率为 10 1.3%， RSD 为 0.6% 。 关键词:依达拉奉注射液; L- 半脱氨酸盐酸盐:柱前衍生化;高效液相色谱:测定 中图分类号: TQ460.7+2; 0657.7+2 文献标志码:A 文章编号: 1001-8255 (2016) 06-0780-03 DOI: 10.16522/j.c也i.cjph.20 16.06.024 Determination ofL-Cysteine Monohydrochloride in Edaravone Injection by HPLC with Pre-column Derivatization 1 1 2 1 NI Meiping , BIAN Wei , CHEN Ying , YANG Yanr , HE Jun (I. National Pharmaceutical Engineering and Research Center, China State Institute 01Pharmaceutical Indust.吵\ Shanghai 201213; 2. Sinopharm Xinjiang Pharmaceutical Co., Ltd. , Urumqi 830032) ABSTRACT: An HPLC method with pre-column derivatization was established for the determination ofL-cysteine monohydrochloride in edaravone i均ection. 2,4-Dinitrochlorobenzene was used 副 the pre-column derivating agent. A Diamonsil C18 column was used, with the mobile phase of acetonitrile : 0.01 moVL disodium hydrogen phosphate solution (哨usted 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 10-30μg/ml. The average recove可 was 101.3%, withRSDofO.6%. Key Words: edaravone injection; L-cysteine monohydrochloride; pre-column derivatization; HPLC; determination 依达拉奉注射液是一种改善急性脑梗死所致的