HPLC-ELSD法测定复方甘露醇注射液中甘露醇及葡萄糖的含量  

Determination of Mannitol and Glucose in Compound Mannitol Injection by HPLC-ELSD

作　　者：高青[1] 周立春[1] 田静[2] 

机构地区：[1]北京市药品检验所,北京100035 [2]北京双鹤药业股份有限公司,北京100088

出　　处：《药物分析杂志》2005年第5期579-581,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立同时测定复方甘露醇注射液中甘露醇及葡萄糖的含量方法。方法:应用高效液相色谱-蒸发光散射检测器,氨基硅烷键合硅胶为填充剂的色谱柱(5μm,250mm×4.6mm),乙腈-水(85∶15)溶液为流动相,流速为1.4mL·min^(-1),漂移管温度为100℃,载气(空气)流速为2.74mL·min^(-1)。结果:葡萄糖在0.6-1.4mg·mL^(-1)范围内线性关系良好(r=0.9980,n=6),回收率为100.8%(RSD 为0.9%,n=9)。甘露醇在0.3-9.0mg·mL^(-1)范围内线性关系良好(r=0.9992,n=6),回收率为100.1%(RSD 为1.0%,n=9)。结论:该方法简便准确,重现性好,可作为本产品的质量控制方法。Objective:To establish a method to determine the content of mannitol and glucose in compound manni- tol injection.Method:ELSD was used to determine mannitol and glucose.The separation was performed on NH_2 col- umn(5μm,250mm×4.6mm)with acetonitrile-water(85:15)as mobile phase.The flow rate was 1.4mL· min^(-1).The temperature of drift tube for measurement was 100 ℃ and the flow rate of air was 2.74mL·min^(-1). Results:The linear range of glucose was 0.6-1.4mg·mL^(-1)(r=0.9980,n=6),the average recovery was 100.8%(RSD=0.6%,n=9).The linear range of mannitol was 0.3-9.0mg·mL^(-1)(r=0.9992,n=6),the av- erage recovery was 100.1%(RSD=1.0%,n=9).Conclusion:This method is simple,accurate and reproducible, The method can be used for the quality control of mannitol and glucose.

关 键 词：复方甘露醇注射液 HPLC-ELSD法 葡萄糖 蒸发光散射检测器 高效液相色谱 质量控制方法 线性关系 含量方法 同时测定 回收率 色谱柱 填充剂 流动相 重现性 流速 

分 类 号：R927.12[医药卫生—药学] R927.2