HPLC-ELSD 法测定红霉素肠溶片中红霉素的含量  

Content Determination of Erythromycin in Erythromycin Enteric-Coated Tabletsby HPLC-ELSD

作　　者：叶宝玉 邹波 陈日檬 梁敏 Ye Baoyu;Zou Bo;Chen Rimeng;Liang Min(Zhanjiang Institute for Food and Drug Control,Zhanjiang 524000,China)

机构地区：[1]湛江市食品药品检验所,广东湛江524000

出　　处：《广东化工》2024年第23期121-124,共4页Guangdong Chemical Industry

基　　金：广东省药品监督管理局科技创新项目重点实验室专项(2020ZDB15)。

摘　　要：目的:建立HPLC-ELSD法测定红霉素肠溶片中红霉素的含量。方法:色谱柱使用纳谱分析C_(18)柱(4.6 mm×150 mm,5μm);流动相使用0.1 mol/L的甲酸铵溶液(pH=6.8)与乙腈(HPLC Grade)按比例混合均匀(65∶35);柱温设置为30℃;流速设置为0.5 mL/min;ELSD检测器中漂移管温度设置为60℃,氮气流速为20 psi;进样量为10μL。结果:红霉素标准品溶液进样量在4.680μg~9.770μg(r=0.9990)范围内线性良好;平均加样回收率为100.29%,RSD为1.05%(n=6);其他方法学实验符合要求。结论:该方法专属性好且简便、灵敏、准确,可用于红霉素肠溶片中红霉素含量的测定。Objective:To establish HPLC-ELSD analytical method for the content determination of erythromycin in erythromycin enteric-coated tablets.Methods:The column is Nano ChromCore C_(18)(5μm,4.6mm×150 mm),the mobile phase is prepared by mixing 0.1 mol/L ammonium formate solution(pH=6.8)and acetonitrile(HPLC Grade)in proportion(65∶35),the flow rate is 0.5 mL/min,and the column temperature is 30℃.The gas flow rate in ELSD detector is 20 psi,and the drift tube temperature is 60℃.Results:The linearity of erythromycin standard solution is good in the range of 4.680μg~9.770μg(r=0.9990);the averagesample recovery rate is 100.29%,with an RSD of 1.05%(n=6);other methodological experiments are in accordance with the requirements.Conclusion:Thismethod has good specificity,is simple,sensitive,and accurate.It can be used for the content determination of erythromycin in erythromycin enteric-coated tablets.

关 键 词：高效液相色谱法 蒸发光散射检测器 红霉素 红霉素肠溶片 含量测定 

分 类 号：R927.1[医药卫生—药学]