HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比
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篇名: HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比
TITLE:
摘要:

目的:建立测定注射用门冬氨酸鸟氨酸含量和摩尔比的方法。方法:采用高效液相色谱法。色谱柱为Thermo

HYPERSIL Aps-2 氨基柱,流动相为乙腈-0.05 mol/L 磷酸二氢钾溶液,流速为0.9 ml/min,柱温为30 ℃,检测波长为200 nm,进样量

为20 μl。并将HPLC法所得结果与电位滴定法结果进行比较。结果:门冬氨酸鸟氨酸的检测质量浓度线性范围为0.02~10.01

mg/ml(r=0.999 9);精密度、稳定性、重复性试验的RSD<2%;回收率为99.15%~100.15%,RSD=0.35%(n=9)。3 批样品含量

为100.04%~100.64%,相对摩尔比为0.982~0.989,含量测定结果与国家标准采用的电位滴定法测定结果相当。结论:该方法简

便、准确、专属性强、灵敏度高,适用于注射用门冬氨酸鸟氨酸的含量和摩尔比测定。

ABSTRACT:

OBJECTIVE:To establish a method for the determination of the content and molar ratio of Ornithine aspartate for injection.

METHODS:HPLC was performed on the column of Thermo HYPERSIL Aps-2 amino column with mobile phase of acetonitrile-

0.05mol/L Potassium dihydrogen phosphate solution,the flow rate was 0.9 ml/min,the column temperature was 30 ℃,the detection

wavelength was 200 nm,and the injection volume of 20 μ l. 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,stability

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 determined

by potentiometric titration with national standards. CONCLUSIONS:The method is simple,accurate,specific and sensitive,

and suitable for the determination of the content and molar ratio of Ornithine aspartate for injection.

期刊: 2016年第27卷第3期
作者: 任连杰,张伟,武晗燕,高恒莹,李群
AUTHORS: REN Lianjie,ZHANG Wei,WU Hanyan,GAO Hengying,LI Qun
关键字: 注射用门冬氨酸鸟氨酸;高效液相色谱法;含量;摩尔比
KEYWORDS: Ornithine aspartate for injection;HPLC;Content;Molar ratio
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