摘要
目的:建立测定小儿复方赖氨酸颗粒中盐酸赖氨酸的定量测定方法。方法:氨基酸分析仪定量测定,色谱柱为阳离子树脂柱LCA K06/Na(150 mm×4.6 mm,7μm),以柠檬酸缓冲液A(pH 3.45)与柠檬酸缓冲液B(pH 10.85)梯度洗脱为流动相,检测波长为570 nm和440 nm,流速为0.45 ml·min^(-1)。结果:盐酸赖氨酸在2.692~21.536μg·ml^(-1)范围内与峰面积呈良好的线性关系,r=0.999 5,平均加样回收率为98.85%,RSD为0.63%(n=9)。结论:该方法灵敏度高,操作简单,重复性好,可用于小儿复方赖氨酸颗粒的质量控制。
Objective： To establish a quantitative method for the determination of lysine hydrochloride in pediatric compound lysine granules. Methods： The quantitative determination was performed on an amino acids analyzer. The cationic resin column（ 150 mm× 4.6 mm,7 μm）was used. The mobile phase was citrate buffer solution （pH 3.45） and citrate buffer solution （pH 10.85） with gradient elution at a flow rate of 0.45 ml ·min - 1. The detection wavelengths were set at 570 nm and 440 ran. Results： The linear range of lysine hydrochloride was 2.692-21. 536 μg · ml -1 （r = 0. 999 5）, and the average sample recovery was 98.85% with RSD of 0.63% （ n = 9）. Conclusion ： The method is sensitive, simple and reproducible. It can be used for the quality control of pediatric compound lysine granules.
出处
《中国药师》
CAS
2016年第2期367-368,共2页
China Pharmacist
基金
国家药品标准提高行动计划(药典综发[2014]322号文
编号:240)
关键词
小儿复方赖氨酸颗粒
盐酸赖氨酸
氨基酸分析仪
含量
Pediatric compound lysine granules
Lysine hydrochloride
Amino acids analyzer（AAA）
Content
