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目的:建立氨基酸含量的柱前衍生化HPLC的定量测定方法。方法:采用OPA-FMOC柱前衍生化法测定复方氨基酸注射液中各个氨基酸的含量并用内、外标法进行了方法比较。结果:表明2种方法在0.025～2.5μmol.mL-1范围内线性关系良好,相关系数在0.9994～1.000之间,平均回收率96.2%～103.6%,RSD<1.4%(n=6),重复性RSD为0.08%～2.82%(n=6),最低定量限0.2～1.1ng。结论:该方法准确、灵敏、简便。内、外标法均适用于各个氨基酸的含量测定。
Objective: To establish a method for the quantitative determination of amino acids by pre-column derivatization HPLC. Methods: The content of each amino acid in Compound Amino Acid Injection was determined by OPA-FMOC pre-column derivatization. The methods were compared by internal and external standard methods. The results showed that the two methods showed a good linearity in the range of 0.025-2.5 μmol · mL-1, the correlation coefficients ranged from 0.9994 to 1.000, the average recoveries ranged from 96.2% to 103.6% with RSDs <1.4% (n = 6) Sex RSD was 0.08% ~ 2.82% (n = 6), the lowest limit of quantification was 0.2 ~ 1.1ng. Conclusion: This method is accurate, sensitive and easy. Internal and external standard methods are applicable to the determination of the content of each amino acid.