摘要
目的建立反相高效液相色谱法测定乙酰谷酰胺注射液的有关物质。方法采用Diamonsil C18(4.6 mm×250 mm,5μm)色谱柱,流动相:0.05 mol.L-1磷酸二氢钾(以10%磷酸调节pH至3.0)-甲醇(95∶5),检测波长:210 nm,流速:0.8 mL.min-1,柱温:25℃。结果乙酰谷酰胺与有关物质可完全分离。结论该方法操作简便、快速、结果准确,可用于该制剂的质量控制。
Objective To establish an RP-HPLC method for the determination of relevant substance in aceglutamide injection.Methods RP-HPLC was performed on Diamonsil C18（4.6 mm×250 mm,5 μm）.The mobile phase consis-ited of 0.05 mol·L-1 potassium dihydrogen phosphate solution（adjusting pH to 3.0 with 10% phosphonic acid）-methanol（95∶5）.The detection wavelength was 215 nm.The flow rate was 0.8 mL·min-1.The column temperature was 25 ℃.Results Relevant substance and aceglutamide were well separated.Conclusion This method is simple,rapid,accurate,and can be used for the quality control of aceglutamide injection.
出处
《中南药学》
CAS
2010年第11期808-811,共4页
Central South Pharmacy
基金
国家药典委员会中国药典2010年版项目
