| HPLC法测定国产莫匹罗星软膏的含量及有关物质 |
| 投稿时间：2014-12-11 修订日期：2015-01-13 点此下载全文 |
| 引用本文：吕亚光,吕昭云,潘显道.HPLC法测定国产莫匹罗星软膏的含量及有关物质[J].医学研究杂志,2015,44(9):138-141 |
| DOI：
10.11969/j.issn.1673-548X.2015.09.039 |
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| 中文摘要: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/L pH6.3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,R2=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。 |
| 中文关键词:高效液相色谱法 莫匹罗星软膏 含量 有关物质 |
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| Determination of Related Substance and Assay Method of mupirocin ointment by HPLC |
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| Abstract: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 C8 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 C18 column with acetonitrile-0.05mol/L pH 6.3phosphate buffer solution (28∶ 72) as mobile phase. The UVdetector 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 Mupirocin. 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. |
| keywords:HPLC Mupirocin ointment Assay Related substance |
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