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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 |
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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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