奥拉西坦葡萄糖注射液中奥拉西坦含量及其有关物质的分析  

Determination of Oxiracetam and Related Substances in Oxiracetam Glucose for Injection by HPLC

作　　者：苏彦文[1] 张凤荣 苏彦斌[3] 许永超[3] 王旭峰[3] 

机构地区：[1]吉林化工学院教务处,吉林吉林132022 [2]吉林省食品药品检验所化学研究室,吉林长春130033 [3]吉林化工学院化学与制药工程学院,吉林吉林132022

出　　处：《吉林化工学院学报》2014年第7期38-41,共4页Journal of Jilin Institute of Chemical Technology

基　　金：吉林省科技发展支撑计划中药;生物药重点项目(20120946);吉林化工学院博士基金项目(20120121)

摘　　要：目的:建立高效液相色谱法测定奥拉西坦葡萄糖注射液中奥拉西坦及其有关物质的方法.方法:色谱柱为ZORBAX SB-Aq C18柱(250×4.6 mm,5μm),以0.02 mol·L-1磷酸二氢钾(用磷酸调节pH至2.0),检测波长为210 nm,流速为0.6 mL·min-1,柱温:30℃.结果:奥拉西坦进样量在0.16μg～1.98μg范围内线性关系良好(r=1.0,n=6).平均回收率为99.42%,RSD=0.62%(n=9).结论:方法准确可靠,可作为奥拉西坦葡萄糖注射液的质量控制方法.OBJECTIVE： To establish a HPLC method for determining the content of oxiracetam and related substances in oxiracetam glucose for injection. METHODS： ZORBAX SB-Aq C18（ 250 mm × 4. 6 mm,5 μm）column was used; the mobile phases consisted of 0. 02 mol·L^- 1potassium dihydrogen phosphate adjusting pH to 2. 0 with phosphoric acid; at a flow rate of 0. 6 mL·min^- 1; the detection wavelength was set at 210 nm,and the column temperature was 30 ℃. RESULTS： The sample size in determination by HPLC for oxiracetam was between 0. 16 μg and 1. 98 μg for ideal linearity,r = 1. 0,n = 6; the average recoveries was 99. 42 % with the RSD = 0. 62 %,n = 9. CONCLUSION： The method is accurate and reliable for quality control for oxiracetam in oxiracetam glucose for injection.

关 键 词：奥拉西坦葡萄糖注射液 有关物质 含量测定 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]