Determination of content of acetyl tyrosine in pediatric compound amino acid injection (19 AA-Ⅰ) by HPLC / 中国生化药物杂志

ABSTRACT

Objective To establish a method for HPLC to determine content of acetyl tyrosine in pediatric compound amino acid injection (19AA-Ⅰ).Methods The chromatographic separation was achieved on a Agilent Hypersil ODS column (250 mm ×4.0 mm,5 μm) with Agilent 1200 liquid chromatography system.The mobile phases consisted of 20 mmol/L sodium dihydrogen phosphate solution ( adjusting pH to 2.5 with phosphoric acid)-acetonitrile (9010) at a flow rate of 1.0 mL/min, the detection wavelength was 210 nm, the column temperature was 25℃.Results Acetyl tyrosine was completely separated from other amino acids.The calibration curves for acetyl tyrosine revealed good linearity in the range of 12.062-120.62μg/mL (r=0.9999).The average recoveries (n=9) of acetyl tyrosine was 100.0%, RSD% (n=9) was 0.9.The limits of quantification (S/N=10) was 0.15μg/mL.Conclusion The methodological validation results indicate that the established method can be applied to quality control of acetyl tyrosine in pediatric compound amino acid injection (19AA-Ⅰ).