HPLC法测定国产莫匹罗星软膏的含量及有关物质  

Determination of Related Substance and Assay Method of mupirocin ointment by HPLC

作　　者：吕亚光 吕昭云 潘显道[2] 

机构地区：[1]北京协和药厂,102600 [2]中国医学科学院/北京协和医学院药物研究所,100050

出　　处：《医学研究杂志》2015年第9期138-141,共4页Journal of Medical Research

摘　　要：目的建立HPLC法测定莫匹罗星软膏的含量及有关物质。方法有关物质采用C8柱，流动相为四氢呋喃-7．7g／L醋酸铵（用冰醋酸调节pH值至5．7）（28：72），检测波长为240nm；含量测定采用C8柱，流动相为乙腈-0．05mol／LpH6．3磷酸盐缓冲液（28：72），检测波长为230nm。结果在有关物质测定中，莫匹罗星线性范围为2．5～50μg／ml，R^2=0．9994，莫匹罗星与杂质能完全分离；在含量测定中，平均回收率为100．5％。结论建立了简便、准确且适合国内常规检测的方法，可以有效地控制莫匹罗星软膏质量。Objective To establish HPLC methods for the determination of Mupirocin Ointment and its related substance. Methods The chromatographic analysis for the related substance was performed on Cs column, tetrahydrofuran- 7.7g/L ammonium acetate（ adjusted the pH to 5.7 by acetic acid） （28： 72） as mobile phase. Detection wavelength was 240nm. The HPLC system for the assay of Mupirocin consisted of Cls column with acetonitrile- 0.05mol/L pH 6.3phosphate buffer solution （28： 72） as mobile phase. The UVderector wavelength was 230nm. Results The linear range was 2.5 - 50.0μg/ml （ R2 = 0. 9994） by the determination of related substance. The related substances were separated from Mupiroein. The average recovery rate was 100.5% by the assay determination. Conclusion Simple,accurate andsuitable methods are established for domestic routine testing,which can control quality of Mupirocin effectively.

关 键 词：高效液相色谱法 莫匹罗星软膏 含量 有关物质 

分 类 号：R9[医药卫生—药学]