柱前衍生HPLC法测定复方氨基酸注射液(20AA)中氨基酸含量  

Determination of Amino Acids in Compound Amino Acid Injection(20AA) by HPLC after Pre-column Derivatization

作　　者：方方 纪宇 

机构地区：[1]江苏省食品药品监督检验研究院,南京210008

出　　处：《中国药品标准》2016年第1期28-31,共4页Drug Standards of China

摘　　要：目的:建立柱前衍生高效液相色谱法测定复方氨基酸注射液(20AA)中包括门冬酰胺和盐酸鸟氨酸在内的18种氨基酸含量的方法。方法:以6-氨基喹啉-N-羟基琥珀酰亚胺基氨基甲酸酯(AQC)为衍生化试剂,以γ-氨基丁酸为内标,采用Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,以140 mmol·L^(-1)醋酸铵缓冲液(p H 5.10)和乙腈-水(57∶43)溶液为流动相进行梯度洗脱,检测波长为248 nm,进样量5μL。结果:18种氨基酸在1.2~108.8μg·m L^(-1)范围内浓度与峰面积线性相关,相关系数为0.994 7~0.999 7;在标示浓度的80%、100%、120%三个浓度水平的平均回收率为97.4%~103.1%,RSD为1.3%~3.7%(n=9)。结论:本法操作简便,结果准确,优于现行标准的方法。Objective： To establish a new HPLC method for the determination of 18 kinds of amino acids, including asparagine and ornithine hydrochloride in Compound Amino Acid Injection（20AA）. Methods： With γ-aminobutyric acid as internal standard, after pre-column derivatization with 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate （ AQC）, 5 ILL of amino acids derivatives was injected and separated on a Kromasil C18 column（4. 6 mm × 250 mm, 5μm）with 140 mmol · L^-1 ammonium acetate buffer solution as mobile phase A and acetonitrile-water （57：43） as mobile phase B, and detected at 248 nm. Results：18 kinds of amino acids derivatives showed good linearity （r =0. 994 7 -0. 999 7） in the range of 1.2 - 108.8μg · mL^-1. The average recoveries of high, middle and low concentration were 97.4% - 103.1% with RSD of 1.3% - 3.7% （ n = 9 ） , respectively. Conclusion： This method was convenient, accurateand superior to the working standard method.

关 键 词：复方氨基酸注射液(20AA) 6-氨基喹啉-N-羟基琥珀酰亚胺基氨基甲酸酯(AQC) 柱前衍生化 含量测定 

分 类 号：R921.2[医药卫生—药学]