HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比_任连杰.pdf

HPLC法测定注射用门冬氨酸鸟氨酸的含量和摩尔比 任连杰 1，2＊，张 伟 1，武晗燕 1，高恒莹 1，李 群 1 （# 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-0.05 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。 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 REN Lianjie1，2，ZHANG Wei1，WU Hanyan1，GAO Hengying1，LI Qun（1 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 0.9 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