HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比-中国药房.PDFVIP

HPLC 法测定注射用门冬氨酸鸟氨酸的含量和摩尔比 1，2＊ 1 1 1 1# 任连杰 ，张 伟 ，武晗燕 ，高恒莹 ，李 群 （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） 中图分类号 R927.2 文献标志码 A 文章编号 1001-0408（2016）03-0383-03 DOI 10.6039/j.issn. 1001-0408.2016.03.33 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-0.05mol/L 磷酸二氢钾溶液，流速为0.9ml/min ，柱温为30℃，检测波长为200nm ，进样量 为20μl。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 ＝0.9999）；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。 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 Content and Molar Ratio Deteremination of Ornithine Aspartate for Injection by HPLC 1，2 1 1 1 1 REN Lianjie ，ZHANG Wei ，WU Hanyan ，GAO Hengying ，LI Qun （1.Beijing Institute for Drug Control ，Bei- jing 100035，China ；2.Center for Drug Evaluation ，CFDA ，Beijing 100038，China ） 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 0.9ml/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 0.02-10.01mg/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- termine