HPLC-ELSD法测定琥乙红霉素片中琥乙红霉素的含量  

Content Determination of Erythromycin Ethylsuccinate in Erythromycin Ethylsuccinate Tablet by HPLCELSD

作　　者：李志得 张彩云 汪霞 

机构地区：[1]鄂州市食品药品检验检测中心,湖北鄂州436099

出　　处：《中国药房》2016年第33期4744-4746,共3页China Pharmacy

摘　　要：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=0.999 2）;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。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 0.304μg, the limits of detection was 0.076 μg, respectively; 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 reproducibility, and can be used for the content determination of Erythromycin ethylsuccinate tablet.

关 键 词：琥乙红霉素片 高效液相色谱法 琥乙红霉素 含量测定 

分 类 号：R917[医药卫生—药物分析学]