高效液相色谱法蒸发光散射检测器测定地高辛片中地高辛的含量  

Determination of Digoxin in Its Tablets by HPLC-ELSD

作　　者：张晴[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《药物分析杂志》2005年第3期329-330,共2页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC-ELSD法测定地高辛片中地高辛的含量。方法:色谱柱:Lichrosphere100 RP-18(250mm×4.6mm5μm);流动相:甲醇-乙腈-水=(48∶10∶42),流速:1.0mL·min^(-1),ELSD-2000检测器,漂移管温度:119℃,气体:空气,流速:2.3L·min^(-1)。结果:地高辛在2.2-13.2μg范围内对数的线性关系良好(r=0.9995)。平均回收率为:100.9%;RSD为:0.73%(n=9)。结论:本法快速,简便,准确,重现性好。可作为地高辛片质量控制的方法。Objective: To develop a HPLC-ELSD method for determining the contents of Digoxin in Digoxin tablets. Methods: The analytical column was Lichrosphere 100 RP-C_(18)(250 mm×4. 6 mm 5 μm);The mobile phase was methanol-acetonitrile-water(48: 10:42);The flow rate was 1.0 mL·min^(-1). An eveaporative light-scattering detector (ELSD) Model 2000, the drift tube temperature: 119℃. The gas flow rate 2. 3 L·min^(-1). Results: In the scope of 2. 2-13. 2 μg the contents of Digoxin had good linear relationship with their peak area(r= 0. 9995), The average recoveries were 100. 9%; RSD= 0. 73% (n= 9). Conclusion: The results showed that the method was rapid, simple, excellent precision. It can be used for the drug quality control.

关 键 词：地高辛片 蒸发光散射检测器 含量 高效液相色谱法 ELSD HPLC RP 甲醇 乙腈 重现性 

分 类 号：R541.6[医药卫生—心血管疾病] R969.2[医药卫生—内科学]