地塞米松磷酸钠注射液有关物质检查方法的探讨  

Studies on Test of Related Substances in Dexamethasone Sodium Phosphate Injection

作　　者：李洁[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药事》2013年第4期416-419,428,共5页Chinese Pharmaceutical Affairs

摘　　要：目的探讨地塞米松磷酸钠注射液有关物质检查方法。方法采用4根不同规格、不同品牌C18色谱柱;流动相:三乙胺溶液(取三乙胺7.5 mL,加水稀释至1000 mL,用磷酸调节pH值至3.0±0.05)-甲醇-乙腈(55∶40∶5);检测波长:242nm;流速:1.0mL.min-1;柱温:30℃。结果与结论采用流动相为溶剂,以地塞米松磷酸酯和地塞米松制备系统适用性溶液,具有峰形对称、分离度高的优点。而杂质Ⅰ的相对保留时间存在很大差异,此值受很多因素影响,以相对保留时间定位具有不确定性。Objective To investigate test methods for related substances in Dexamethasone Sodium Phosphate Injection. Methods A total of four C18 chromatographic columns of different specifications and brands were adopted with a mobile phase of triethylamine solution （7.5 mL of triethylamine in 1000 mL of water, with phosphoric acid to adjust the pH value to 3.0 ± 0.05） -methanol-acetonitrile （55： 40 ： 5）. The flow rate was 1.0 mL · rain-1 , the detection wavelength 242 nm, the column temperature 30℃. Results and Conclusion The solution with system suitability has advantages of a symmetrical peak shape and a high separation degree using the mobile phrase as the solvent prepared with dexamethasone phosphate and dexamethasone. There is a big difference in the relative retention time of the impurity I. As this value is influenced by many factors, positioning by relative retention time is of uncertainty.

关 键 词：地塞米松磷酸钠注射液 有关物质 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]