Objective To develop an assay method of amino acids in compound amino acid injection(18AA-Ⅱ).Methods The online pre-column OPA-FMOC derivatization method was applied.A Zorbax Eclipse-AAA column was used in the gradient elution with 40 mmol/L NaH2PO4 solution(pH7.8)as mobile phase A and acetonitrile-methanol-water(45:45:10)as mobile phase B,the detection wavelength was 360 nm and 262 nm,and the column temperature was 40℃.Results The separation degree of amino acids was good.All the linear correlation coefficients were no less than 0.9994.The average recoveries were between 99%and 103%,the RSDs of repeatability were less than 2%.Conclusion This method could provide references for the quantitation and evaluation of amino acids in compound amino acid injection with good repeatability,accuracy and efficiency,and a solution to the weak repeatability of lysine peak area in OPA-FMOC derivatization method was reported for the first time.
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