骨化三醇注射液中甘氨酸含量测定方法研究  

Determination of glycine in calcitriol injection

作　　者：靳文仙[1] 李艳贞[1] 刘欢[1] 吴赟[1] 阎卉[1] 王成港[1] 

机构地区：[1]天津药物研究院,天津300193

出　　处：《天津药学》2016年第4期19-21,55,共4页Tianjin Pharmacy

摘　　要：目的：建立HPLC法测定骨化三醇注射液中甘氨酸的含量。方法：采用柱前衍生高效液相色谱法测定，通过实验筛选出柱前衍生化的最佳反应条件。结果：衍生反应的最佳条件为pH8．04，温度20～30℃，反应时间为1．5min，试剂用量1ml。含量测定的方法学验证结果显示该方法专属性好，线性关系、重复性、回收率较好。结论：采用邻苯二甲醛柱前衍生高效液相色谱法能准确测定骨化三醇注射液中甘氨酸含量。Objective ： To establish a method for determination of glycine in calcitriol injection. Methods ： An optimized condition for pre - column derivation of glycine in ealcitriol injection was explored and then the derivative of glycerine was quantitatively de- termined by high performance liquid chromatogrphy. Results： Glycerine was best derivatized with one millimetre at pH 8.04, the reaction temperature of 20 - 30 ℃ and the reaction time of 1.5 min. The determination method was validated in a good specificity, linearity, reproducibility and recovery. Conclusions： The method can be used for the determination of glyeine in calcitriol injec- tion.

关 键 词：高效液相色谱法 柱前衍生 邻苯二甲醛 甘氨酸 骨化三醇注射液 

分 类 号：R927.2[医药卫生—药学]