莫匹罗星软膏中聚乙二醇含量测定方法的建立  

Establishment of Content Determination Method of Polyethylene Glycol in Mupirocin Ointment

作　　者：常祎卓 吴承芷 王立新[1] 宁保明[1] 崇小萌[1] CHANG Yizhuo;WU Chengzhi;WANG Lixin;NING Baoming;Chong Xiaomeng(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药学杂志》2024年第19期1861-1867,共7页Chinese Pharmaceutical Journal

摘　　要：目的建立莫匹罗星软膏中辅料聚乙二醇(PEG)的含量测定方法。方法色谱柱为TSKgel G2000SWXL(7.8 mm×30 cm,5μm),流动相为0.1 mol·L^(-1)硝酸钠溶液(用磷酸调节pH值为3.0)-乙腈(95∶5),示差折光检测器,检测器温度为35℃,柱温为35℃,流速为1.0 mL·min^(-1),进样体积为20μL。结果建立了3种不同PEG的含量测定方法,并对不同厂家莫匹罗星软膏中PEG的种类及含量进行了测定。此方法中,PEG400、PEG3350及PEG4000的检测限均为0.01 mg·mL^(-1),定量限均为0.02 mg·mL^(-1),线性范围均为0.2~5.0 mg·mL^(-1),平均回收率分别为99.3%、99.8%和100.2%(n=9)。结论所建立的PEG含量测定方法高效、快速、准确、灵敏,可对莫匹罗星软膏中不同种类PEG的含量进行控制。OBJECTIVE To establish content determination method of polyethylene glycol(PEG)in mupirocin ointment.METHODS The content determination method of PEG was performed on TSKgel G2000SWXL column at 35℃using refractive index detector at 35℃,0.1 mol·L^(-1)NaNO3(pH 3.0)was used as mobile phase and the flow rate was 1.0 mL·min^(-1),and the injection volume was 20μL.RESULTS The content determination method of three different PEG in mupirocin ointment was established.The type and content of PEG in mupirocin ointment from different manufacturers were determined.In this method,the limits of detection(LOD)for PEG400,PEG3350,and PEG4000 were all 0.01 mg·mL^(-1).The limits of quantitation(LOQ)were all 0.02 mg·mL^(-1),and the ranges of linearity were all 0.2 to 5.0 mg·mL^(-1).The average recoveries were 99.3%、99.8%and 100.2%,respectively(n=3).CONCLUSION The established method is efficient,rapid,accurate and sensitive,which can be used as the content determination method of PEG in mupirocin ointment.

关 键 词：莫匹罗星软膏 聚乙二醇 含量测定 示差折光检测器 

分 类 号：R917[医药卫生—药物分析学]