莫匹罗星软膏有关物质测定方法的建立

目的 建立莫匹罗星软膏有关物质HPLC分析方法。方法 采用Agilent Zorbax C8(250mm×4.6mm, 5μm)色谱柱，柱温：30℃，流动相：以pH5.7乙酸铵溶液-四氢呋喃不同比例线性梯度洗脱，流速：0.8mL/min，检测波长：240nm，进样量：20μL。结果 莫匹罗星及莫匹罗星杂质C、D、E分别在25~100μg/mL浓度范围内线性关系良好；定量限分别为0.016、0.047、0.019及0.020μg；杂质C、D和E的平均回收率分别为103.7%、98.6%和93.9%；重复性RSD均小于1.0%；酸、碱、高温、氧化、光照强制降解试验证明方法的专属性良好。结论 所建立的方法专属性、准确性及耐用性均良好，可用于莫匹罗星软膏有关物质的检测。

Establishment of a method for related substances of mupirocin ointment

Objective To construct a method for related substances of mupirocin ointment by HPLC. Methods The HPLC analysis was performed on an Agilent Zorbax C8(250mm×4.6mm, 5μm)column and the column temperatures was 30℃. The mobile phase consisted of ammonium acetate solution at pH5.7 and tetrahydrofuran with a gradient elution at the flow rate of 0.8mL/min. The detection wavelength was 240nm and the injection volume was 20μL. Results Mupirocin, mupirocin impurities C, D, and E had good linear relationship at the range of 25~100μg/mL. The limit of quantitative of mupirocin, mupirocin impurities C, D, and E were respectively 0.016, 0.047, 0.019 and 0.020μg. The average recovery of mupirocin impurities C, D, and E were respectively 103.1%, 98.6%, and 93.8%. The RSD of repeatability of the three kinds of impurities was all less than 1.0%. Acid, alkali, high temperature, oxidation, and light forced degradation tests proved that the method had good specificity. Conclusion The method was proved to be specific, accurate, and durable, which was suitable for the related substance analysis of mupirocin