二肽类药物甘氨酰谷氨酰胺有关物质检测方法的研究  

Study on the specific detection methods of glycyl-glutamine related substances

作　　者：李洁 王惠瑾[2] 黄国英 

机构地区：[1]山东齐都药业有限公司,山东淄博255400 [2]天津中医药大学中药学院,天津300193

出　　处：《药学研究》2013年第4期217-219,共3页Journal of Pharmaceutical Research

摘　　要：目的建立二肽类药物甘氨酰谷氨酰胺有关物质检测方法,为甘氨酰谷氨酰胺的质量控制以及工艺评价提供有效的方法。方法采用Kromsial NH2(4.6 mm×250 mm,5μm)色谱柱;以0.01 mol.L-1磷酸二氢钠溶液(用磷酸调节pH值至2.5)-乙腈(40∶60)为流动相,流速为1.0 mL.min-1;检测波长为215 nm。结果所建立的高效液相色谱检测方法能分离各组分,具有较好的精密度、准确度和稳定性。结论采用高效液相色谱检测方法简单,精密度好,准确度高,可用于甘氨酰谷氨酰胺中环(甘氨酰-谷氨酰胺)、L-焦谷氨酸、甘氨酰甘氨酰谷氨酰胺、甘氨酰谷氨酸四种已知杂质和未知杂质的质量控制和工艺评价。Objective To establish a method for related substances of glycyl - glutamine, a dipeptide drugs and to provide an effective way for quality control and process evaluation of glycyl - glutamine. Methods HPLC analysis was performed on a Kromsial NH2 column（4.6 mm x250 ram,5 μm）. The mobile phase was 0.01 min^-1 sodium dihydrogen phosphate solution（ adjusted to pH 2.5 with phosphoric acid） - acetonitrile（40：60）. The flow rate was 1.0 mL .min^-1 and the detection wavelength was 215 nm. Results The HPLC method could well separated the components of glycyl - gluta- mine, and it＇s better precision, accuracy and stability. Conclusion The method was simple, good precision and high accu- racy, and it can be used for the quality control and process evaluation of four impurities in glycyl - glutamine, cyclo （ glycyl - glutamine L - pyroglutamic acid, glycyl - glycyl - glutamine, glycyl - glutamate and unknow impurities.

关 键 词：甘氨酰谷氨酰胺 环(甘氨酰-谷氨酰胺) L-焦谷氨酸 甘氨酰甘氨酰谷氨酰胺 甘氨酰谷氨酸 有关 物质 高效液相色谱 

分 类 号：R927.11[医药卫生—药学]