高效液相色谱法测定注射用二乙基二硫代氨基甲酸钠中主药的含量

Determination of Diethyldithiocarbamate in Sodium Diethyldithiocarbamate by HPLC

目的：建立以高效液相色谱法测定注射用二乙基二硫代氨基甲酸钠（DDC）中DDC含量的方法。方法：色谱柱为Phenomenex C8，流动相为含0．0125mol／L四丁基氯化铵的0．1％磷酸盐缓冲液（pH=6．3）-甲醇（65：35），流速为1.0ml／min，检测波长为257nm，进样量为20μl。结果：DDC检测浓度在50～800μg／ml范围内线性关系良好（r=0．9998），平均回收率为99．53％（RSD=0．98％）。结论：本方法简便、快捷、可靠，可用于注射用DDC的质量控制。

OBJECTIVE： To establish a HPLC method for the determination of diethyldithiocarbamate in the sodium diethyldithiocarbamate（DDC） for injection.METHODS： The determination was performed on Phenomenex C8, the mobile phase consisted of 0.1% phosphate buffer（pH = 6.3） （which contained 0.0125mol/ L tetrabutyl ammonium chloride） -methanol （65 ： 35） with a flow rate of 1.0ml/min, the detection wavelength was 257nm and the sample size was 20μl. RESULTS： The linear detection concentration range of DDC was 50～800μg/ml（r = 0.9998）, the average recovery was 99.83% （RSD = 0.98% ）.CONCLUSIONS：The method was simple,rapid and reliable,and suitable for the quality control of DDC for injection.