CAJ | 학술논문

目的：建立测定小儿复方氨基酸注射液（19AA－Ⅰ）中乙酰酪氨酸含量的高效液相色谱法（high performance liquid chromatography，HPLC）。方法采用Agilent 1200型高效液相色谱仪，使用Agilent Hypersil ODS色谱柱（250 mm ×4．0 mm，5μm），以20 mmol／L磷酸二氢钠溶液（用磷酸调节pH值至2．5）－乙腈（90：10）为流动相，流速1．0 mL／min，检测波长210 nm，柱温25℃。结果乙酰酪氨酸峰与其他氨基酸色谱峰分离度良好，乙酰酪氨酸在12．062～120．62μg／mL范围内呈良好的线性关系（ r＝0．9999），平均加样回收率（n＝9）为100．0％，RSD％（n＝9）为0．9，其定量限（S／N＝10）为0．15μg／mL。结论建立的HPLC法可用于小儿复方氨基酸注射液（19AA－Ⅰ）中乙酰酪氨酸的质量控制。
목적：건립측정소인복방안기산주사액（19AA－Ⅰ）중을선락안산함량적고효액상색보법（high performance liquid chromatography，HPLC）。방법채용Agilent 1200형고효액상색보의，사용Agilent Hypersil ODS색보주（250 mm ×4．0 mm，5μm），이20 mmol／L린산이경납용액（용린산조절pH치지2．5）－을정（90：10）위류동상，류속1．0 mL／min，검측파장210 nm，주온25℃。결과을선락안산봉여기타안기산색보봉분리도량호，을선락안산재12．062～120．62μg／mL범위내정량호적선성관계（ r＝0．9999），평균가양회수솔（n＝9）위100．0％，RSD％（n＝9）위0．9，기정량한（S／N＝10）위0．15μg／mL。결론건립적HPLC법가용우소인복방안기산주사액（19AA－Ⅰ）중을선락안산적질량공제。
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 (90:10) 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).