门冬氨酸鸟氨酸注射液中的有关物质检查

Determination of the Related Substances in Ornithine Asparate Injection

建立了高效液相色谱法对门冬氨酸鸟氨酸注射液进行有关物质检查。使用氨基色谱柱,以0.05 mol/L磷酸二氢钾溶液(pH 5.5)∶乙腈(47∶53)为流动相,检测波长210 nm。注射液中门冬氨酸、鸟氨酸及其主要杂质L-鸟氨酸内酰胺和富马酸分别在1.07～21.32、1.06～21.18、0.02～48.31和0.01～2.94μg/ml范围内线性关系良好,检测限分别为0.53、0.53、0.004和0.002μg/ml。主要有关物质L-鸟氨酸内酰胺和富马酸的回收率为100.74%和101.44%,RSD值均小于2%。本研究所建方法准确、稳定,分离效率更好,更适合该品种注射液的有关物质检查。

An HPLC method was established for the determination of the related substances in ornithine asparate injections. An amino column was used, with the mobile phase of 0.05 mol/L potassium dihydrogen phosphate solution （pH 5.5）∶acetonitrile （47∶53）, at the detection wavelength of 210 nm. The calibration curves of ornithine, aspartic acid, L-ornithine lactam and fumaric acid were linear in the ranges of 1.07-21.32, 1.06-21.18, 0.02-48.31 and 0.01-2.94 μg/ml. Their limits of detection were 0.53, 0.53, 0.004 and 0.002 μg/ml, respectively. The recoveries of the main known impurities L-ornithine lactam and fumaric acid were 100.74% and 101.44%, with RSDs less than 2%. The method established in our work is accurate and stable, with better separation efficiency, which is more suitable for the determination of the related substances in ornithine asparate injections.