离子排斥色谱法测定复方氨基酸(15)双肽(2)注射液中醋酸含量  

Content determination of acetic acid in compound amino acid(15) peptide(2) injection by ion exclusion chromatography

作　　者：李盼盼[1] 王冉 左利民[1] 赵婷 仇小丹 山广志[1] 姚静[2] LI Pan-pan;WANG Ran;ZUO Li-min;ZHAO Ting;QIU Xiao-dan;SHAN Guang-zhi;YAO Jing(Institute of Medicinal Biotechnology,Chinese Academy of Medical Sciences,Beijing 100050,China;National Institutes for Food and Drug Control,Beijing 100050,china)

机构地区：[1]中国医学科学院医药生物技术研究所,北京100050 [2]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2018年第8期1457-1461,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：重大新药创制科技重大专项(2017ZX09101001);中国医学科学院医学与健康科技创新工程系统创新团队基金(2016-I2M-3-010)

摘　　要：目的:建立复方氨基酸(15)双肽(2)注射液中醋酸含量的离子排斥色谱法。方法:采用Hyper REZ XP carbohydrate H+色谱柱,以0.002 5 mol·L^(-1)硫酸溶液为流动相,流速为0.5 mL·min^(-1),柱温45℃,检测波长210 nm,进样量10μL。结果:醋酸峰与相邻色谱峰分离度良好,醋酸的线性范围为0.184 8～7.391 mg·mL^(-1)(r=1.000,n=5);精密度、稳定性、重复性试验的RSD<2%;加样回收率为101.5%,RSD为1.3%(n=9)。结论:建立的离子排斥色谱法可用于复方氨基酸(15)双肽(2)注射液中醋酸的含量测定。Objective：To establish a ion exclusion chromatography（IEC）method for the determination of acetic acid in compound amino acid（15）peptide（2）injection. Methods：The column was Hyper REZ XP carbohydrate H ＋ with the mobile phase of 0.002 5 mol·L-1 sulfuric acid solution. The flow rate was 0.5 m L·min-1,the column temperature was 45 ℃,the detection wavelength was 210 nm,and the injection volume was 10 μL. Results：The linear range of acetic acid was 0.184 8-7.391 mg·m L-1（r=1.000,n=5）.RSDs of precision,stability and repeatability tests were all lower than 2%. The recovery was 101.5%（ RSD=1.3%,n =9）.Conclusion：The established IEC method can be used for the determination of acetic acid in compound amino acid（15） peptide（2） injection.

关 键 词：复方氨基酸(15)双肽(2)注射液 醋酸 离子排斥色谱法 离子交换色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]