HPLC同时测定复方氨基酸注射液中3个氨基酸的含量  

HPLC simultaneous determination of three amino acids in compound amino acid injection

作　　者：唐敏[1] 袁军 刘峰 朱恒怡 钱广生[1] TANG Min;YUAN Jun;LIU Feng;ZHU Heng-yi;QIAN Guang-sheng(West China School of Pharmacy,Sichuan University,Chengdu 610041,China;Sichuan Food and Drug Testing Institute,Chengdu 610041,China)

机构地区：[1]四川大学华西药学院,成都610041 [2]四川省食品药品检验检测院,成都610041

出　　处：《药物分析杂志》2020年第5期900-909,共10页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法同时测定复方氨基酸注射液中色氨酸、酪氨酸、乙酰酪氨酸的含量。方法:采用Waters Symmetry■C18色谱柱(250 mm×4.6 mm,5μm),流动相为8 mmol·L^-1磷酸二氢钾溶液-甲醇(9∶1),检测波长280 nm,流速1.0 mL·min^-1,柱温35℃。结果:3个氨基酸可完全分离,色氨酸、酪氨酸、乙酰酪氨酸的线性范围分别为12.15~242.96、4.06~81.13、12.36~247.20μg·mL^-1(r均为0.9999),回收率分别为98.0%、99.4%、102.0%(n=9)。7家企业生产的复方氨基酸注射液中色氨酸、酪氨酸、乙酰酪氨酸的含量分别为88.7%~113.8%、89.4%~103.1%、89.9%~101.3%,结果均合格。结论:所用方法可同时测定复方氨基酸注射液中3个氨基酸含量,并为现行标准的提高提供可靠依据。Objective:To establish an HPLC method for the simultaneous determination of tryptophan,tyrosine and N-acetyl-L-tyrosine in compound amino acid injection.Methods:The method was performed on a Waters Symmetry■C18 column(250 mm×4.6 mm,5μm)with isocratic elution of methanol-8 mmol·L^-1 potassium dihydrogen phosphate(1∶9)delivered at a flow rate of 1 mL·min^-1.The detection wavelength set at 280 nm and the column temperature was 35℃.Results:Tryptophan,tyrosine and N-acetyl-L-tyrosine were well separated and their calibration curves were in the respective range of 12.15-242.96,4.06-81.13 and12.36-247.20μg·m L^-1 with correlation coefficients of 0.9999.The average recoveries were 98.0%,99.4%and 102.0%,respectively(n=9).Content determination results of tryptophan,tyrosine and N-acetyl-L-tyrosine in compound amino acid injection from seven manufacturers were all qualified in the ranges of 88.7%-113.8%,89.4%-103.1%and 89.9%-101.3%.Conclusion:The method is suitable for the simultaneous determination of three amino acids in compound amino acid injection.It also provides a reliable basis for the improvement of current standards.

关 键 词：色氨酸 酪氨酸 乙酰酪氨酸 高效液相色谱法 含量测定 标准提高 

分 类 号：R917[医药卫生—药物分析学]