中国药房2016，Vol.27Issue(3)：383-385,3.DOI:10.6039/j.issn.1001-0408.2016.03.33
HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比
Content and Molar Ratio Deteremination of Ornithine Aspartate for Injection by HPLC
任连杰 1张伟 2武晗燕 1高恒莹 1李群1
作者信息
- 1. 北京市药品检验所,北京 100035
- 2. 国家食品药品监督管理总局药品审评中心,北京 100038
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for the determination of the content and molar ratio of Ornithine aspartate for in-jection. METHODS:HPLC was performed on the column of Thermo HYPERSIL Aps-2 amino column with mobile phase of aceto-nitrile-0.05mol/L Potassium dihydrogen phosphate solution,the flow rate was 0.9 ml/min,the column temperature was 30℃,the de-tection wavelength was 200 nm,and the injection volume of 20 μl. The results determined by HPLC and potentiometric titration were compared. RESULTS:The linear range of ornithine aspartate was 0.02-10.01 mg/ml(r=0.999 9);RSDs of precision,stabili-ty and reproducibility tests were lower than 2%;recovery was 99.15%-100.15%(RSD=0.35%,n=9). The content of 3 batches of Ornithine aspartate for injection was 100.04%-100.64% and molar ratio was 0.982-0.989. The content is similar to the results de-termined by potentiometric titration with national standards. CONCLUSIONS:The method is simple,accurate,specific and sensi-tive,and suitable for the determination of the content and molar ratio of Ornithine aspartate for injection.关键词
注射用门冬氨酸鸟氨酸/高效液相色谱法/含量/摩尔比Key words
Ornithine aspartate for injection/HPLC/Content/Molar ratio分类
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任连杰,张伟,武晗燕,高恒莹,李群..HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比[J].中国药房,2016,27(3):383-385,3.
