基于在线柱切换液相色谱技术的红霉素软膏含量测定研究  

Determination of erythromycin ointment content based on on-line column switching and liquid chromatography

作　　者：宁霄[1] 高广慧 金绍明[1] 刘彤彤 裴宇盛[1] 曹进[1] NING Xiao;GAO Guanghui;JIN Shaoming;LIU Tongtong;PEI Yusheng;CAO Jin(National Institutes for Food and Drug Control,Beijing 100050,China;Liaoning Inspection,Examination&Certification Centre,Shenyang Liaoning 110010,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]辽宁省检验检测认证中心,辽宁沈阳110010

出　　处：《中国药物警戒》2024年第2期152-155,180,共5页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2021YFC2401100)。

摘　　要：目的建立在线柱切换高效液相色谱法测定红霉素软膏中主药含量的方法,为相关制剂的质量控制提供有效手段。方法样品经80℃提取后直接进样,柱切换系统下,采用C_(18)(50 mm×2.1 mm,5μm)色谱柱初步分离,2.5 min后转入C_(18)(150 mm×2.1 mm,5μm)柱进行分析,流速0.2 mL·min^(-1),柱温35℃。结果红霉素在1~100μg·mL^(-1)范围内线性关系良好(r=0.9994);平均加样回收率大于96.9%;日内和日间精密度小于1.29%(n=6)。结论本研究改进样品提取方法,并通过在线柱切换完成目标组分的净化和富集,该方法操作简单、准确灵敏、稳定性好,可用于红霉素软膏的含量测定。Objective To establish an on-line column switching high performance liquid chromatography method for determination of the main drugs in erythromycin ointment,and to recommend an effective means for quality control of related preparations.Methods The samples were extracted at 80℃and injected directly.Under the column switching system,the samples were initially separated on a C_(18) chromatographic column(50 mm×2.1 mm,5μm)before being transferred to a second C_(18) column(150 mm×2.1 mm,5μm)for analysis after 2.5 min.The flow rate was 0.2 mL·min^(-1) and the column temperature was 35℃.Results The linear relationship of erythromycin was good within the range of 1~100μg·mL^(-1)(r=0.9994).The average recovery was 96.9%.Intraday and interday precision was less than 1.29%(n=6).Conclusion This study has improved the sample extraction method and completed the purification and enrichment of target components through on-line column switching.This method is simple,accurate,sensitive and stable,which can be used for content determination of erythromycin ointment.

关 键 词：红霉素软膏 在线柱切换法 高效液相色谱 快速提取 含量测定 

分 类 号：R927.2[医药卫生—药学]