HPLC法测定复方氨基酸(15)双肽(2)注射液中醋酸盐和枸橼酸盐的含量  

Determination of acetate and citrate in Compound Amino Acid(15)and Dipeptides(2)Injection by HPLC

作　　者：王艳敏 王娜 于黎鑫 常征 WANG Yanmin;WANG Na;YU Lixin;CHANG Zheng(Shandong Qidu Pharmaceutical Co.,Ltd.,Zibo 255400,China)

机构地区：[1]山东齐都药业有限公司,山东淄博255400

出　　处：《药学研究》2021年第4期232-234,238,共4页Journal of Pharmaceutical Research

摘　　要：目的建立高效液相色谱法测定复方氨基酸(15)双肽(2)注射液中醋酸盐和枸橼酸盐的含量。方法以菲罗门Rezex ROA-Organic Acid H+(7.8 mm×300 mm,8μm)为色谱柱;以水(用硫酸调节pH值至2.7)为流动相;柱温为60℃;流速为0.6 mL·min^(-1);检测波长为210 nm。结果醋酸盐和枸橼酸盐的浓度分别在222~518μg·mL^(-1)和145.2~338.8μg·mL^(-1)范围内与峰面积呈良好的线性关系;精密度、稳定性试验的RSD均小于2.0%;平均回收率分别为100.45%、99.96%。结论该方法专属性强,精密度好,准确度高,可用于复方氨基酸(15)双肽(2)注射液中醋酸盐和枸橼酸盐的含量测定。Objective To establish an HPLC method for the determination of acetate and citrate in Compound Amino Acid(15)and Dipeptides(2)Injection.Methods The assay was performed on a Phenomenex Rezex ROA-Organic Acid H+(7.8 mm×300 mm,8μm)with the column temperature at 60℃,and the mobile phase consisted of water(pH to 2.7 with sulfuric acid)with a flow rate of 0.6 mL·min^(-1).The UV detection wavelength was 210 nm.Results There was a good linear relationship between the concentration of acetate and peak area in the range of 222~518μg·mL^(-1),the concentration of citrate and peak area in the range of 145.2~338.8μg·mL^(-1),respectively.The RSD s of precision and stability tests were less than 2.0%.And the average recoveries of acetate and citrate were 100.45%,99.96%,respectively.Conclusion The method was specific,reproducible,accurate,and can be used for the assay of acetate and citrate in Compound Amino Acid(15)and Dipeptides(2)Injection.

关 键 词：复方氨基酸(15)双肽(2)注射液 高效液相色谱法 醋酸盐 枸橼酸盐 

分 类 号：R927.2[医药卫生—药学]