HPLC-ELSD法测定琥乙红霉素片中琥乙红霉素的含量

摘要

OBJECTIVE:To establish a method for the content determination of erythromycin ethylsuccinate in Erythromycin ethylsuccinate tablet. METHODS:The column of Dikma-C18 with mobile phase of acetonitrile-0.05% diethylamine(70 ∶ 30,V/V)at a flow rate of 1.0 ml/min,column temperature was 30℃,and the sample size was 10μl. RESULTS:The linear range of erythromy-cin ethylsuccinate was 1.216-7.296 μg(r=0.999 2);limit of quantitation was 0.304 μg,the limits of detection was 0.076 μg,re-spectively;the RSDs of precision, stability and reproducibility tests were no more than 2.0%, the average recoveries was 97.59%-104.19%(RSD=1.71%,n=6). CONCLUSIONS:The method is simple and accurate with high sensitivity and reproduc-ibility,and can be used for the content determination of Erythromycin ethylsuccinate tablet.%目的：建立高效液相色谱-蒸发光散射检测器法测定琥乙红霉素片中琥乙红霉素含量的方法。方法：色谱柱为Dikma-C18，流动相为乙腈-0.05％二乙胺（70∶30，V/V），流速为1.0 ml/min，柱温为30℃，进样量为10μl。结果：琥乙红霉素检测进样量线性范围为1.216～7.296μg（r＝0.9992）；定量限为0.304μg，检测限为0.076μg；精密度、稳定性、重复性试验的RSD＜2.0％；加样回收率为97.59％～104.19％（RSD＝1.71％，n＝6）。结论：该方法操作简便、结果准确、灵敏度高、重复性好，可用于测定琥乙红霉素片中琥乙红霉素的含量。