HPLC-ELSD法测定复方氨基酸注射液(3AA)中三组分的含量  

HPLC-ELSD determination of three components in compound amino acid injection(3AA)

作　　者：陈鼎雄[1] 林立[2] 

机构地区：[1]福建省药品检验所,福州350001 [2]福建省中医药研究院,福州350003

出　　处：《药物分析杂志》2007年第10期1649-1651,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立不经衍生用高效液相色谱-蒸发光散射检测法直接测定复方氨基酸注射液(3AA)中 Val、Iso、Leu 的含量测定方法。方法:色谱柱为 Phenomenex Luna C_(18)(4.6mm×250mm,5μm);流动相为0.3%三氯乙酸溶液-乙腈(90:10),流速0.6mL·min^(-1),EISD 漂移管温度109℃,载气流速3.0 L·min^(-1)。结果:Val、Iso、Leu 的线性范围分别为1.008～5.040mg·mL^(-1)(r=0.9992),1.082～5.410mg·mL^(-1)(r=0.9992),1.343～6.714mg·mL^(-1)(r=0.9993);回收率分别为98.7%～100.9%(RSD<0.3%),98.5%～100.7%(RSD<0.2%),98.5%～101.0%(RSD<0.2%)。结论:本法简便快速,准确可靠,适用于复方氨基酸注射液(3AA)中3种组分的同时测定。Objective：To establish a method for the determination of Val, Iso and Leu in compound amino acid in- jection（3AA） using HPLC with evaporative light- scattering detector （ELSD） without derivatization. Method： Chromatography was proformed on a Phenomenex Luna C18 column（4. 6 mm × 250 mm ,5 μm）. The mobile phase was composed of 0. 3% trifluoroacetic acid -acetonitrile （90：10 ） with the flow rate of 0.6 mL · min^-1. The gas flow rate was 3.0 L · min^-1 and the tube temperature was 109 ℃. Result. A satisfactory separation among three components was obtained. The linear response ranges were ： 1. 008 - 5. 040 mg · mL^-1 for Val （ r = 0. 9992） , 1. 082 -5.410 mg · mL^-1 for Iso（r =0. 9992） and 1. 343-6. 714 mg · mL^-1 for Leu（r =0. 9993） respectively. The recoveries of Val,Iso and Leu were 98.7% - 100. 9% （RSD 〈0. 3% ） ,98. 5% - 100. 7% （RSD 〈0. 2% ） ,98.5% -101.0% （RSD 〈0. 2% ） respectively. Conclusion：This method is simple, quick and the result of determination is precise and accurate. This method is suitable for determination of the three Components in compound amino acid injection（3AA）.

关 键 词：高效液相色谱-蒸发光散射检测 复方氨基酸注射液 Val ISO LEU 

分 类 号：R917[医药卫生—药物分析学]