HPLC同时测定复方氨基酸注射液中3个氨基酸的含量

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，5 μm），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、12.36～247.20 μg·mL^-1（r均为0.999 9），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,5 μm)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 and 12.36-247.20 μg·mL^-1 with correlation coefficients of 0.999 9. 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.

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