Development of an HPLC-UV method for the determination of ethaselen in its injection formulation  

高效液相色谱法测定乙烷硒啉注射剂中乙烷硒啉的含量(英文)

作　　者：陈粟[1] 宋平[1] 王颖[1,2] 胡启帜[1] 张烜[1] 张强[1,3] 

机构地区：[1]北京大学医学部药学院药剂学系,北京100191 [2]沈阳药科大学药学院药剂学系,辽宁沈阳110016 [3]北京大学医学部天然药物及仿生药物国家重点实验室,北京100191

出　　处：《Journal of Chinese Pharmaceutical Sciences》2012年第4期321-326,共6页中国药学（英文版）

基　　金：Key Drug Innovation Project of China (Grant No. 2009ZX09102-031)

摘　　要：A novel ethaselen injection formulation has been developed in our laboratory. The objective of the present study was to establish and validate a high performance liquid chromatography （HPLC） method for the determination of ethaselen in its injection formulation. Analysis was performed on an ODS column with isocratic elution at 40 ℃. Mobile phase was consisted of 0.01% phosphoric acid and methanol （60：40, v/v）. The detection wavelength was set at 320 nm and the flow rate was 1.0 mL/min. The results showed that the calibration curves of ethaselen were linear in the range of 10-50 μg/mL （r2 = 0.9999）. The limit of detection for ethaselen was 100 ng/mL. The average recovery of ethaselen was 100.14%. The labeled content of ethaselen in its injection formulation was in the range of 102%-103% of the measured content. In conclusion, this method was stable and reproducible, thus providing a useful tool for the routine analysis of this novel ethaselen injection formulation.采用高效液相色谱法测定乙烷硒啉注射剂中乙烷硒啉的含量。使用ODS色谱柱, 流动相组成0.01%磷酸-甲醇 (60:40, v/v), 流速1.0 mL/min, 柱温40 °C, 检测波长320 nm, 进样体积20 μL。结果表明: 在上述色谱条件下乙烷硒啉色谱峰峰型良好, 在10-50 μg/mL浓度范围内, 乙烷硒啉浓度与峰面积之间线性良好 (r2 = 0.9999), 最低检测限为100 ng/mL, 精密度、日间与日内差、稳定性、回收率均符合要求。自制三批乙烷硒啉注射剂的含量以标示量计, 在102%-103%之间。本法简单、准确、可靠, 可用于乙烷硒啉注射剂含量的测定。

关 键 词：ETHASELEN INJECTION HPLC CONTENT 

分 类 号：R927.2[医药卫生—药学]