Deubel A, Holzgrabe U
Institute of Pharmacy and Food Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany.
J Pharm Biomed Anal. 2007 Jan 17;43(2):493-8. doi: 10.1016/j.jpba.2006.07.044. Epub 2006 Aug 28.
A new HPLC-UV method for the determination of the impurity profile of erythromycin is developed. In contrast to the liquid chromatography described in the European Pharmacopoeia the analysis could be performed at a temperature of 25 degrees C. Erythromycin samples were analysed on an endcapped RP phase with cyanopropyl groups on the surface using gradient elution with 32 mM potassium phosphate buffer pH 8.0 and acetonitrile/methanol (75:25). The aforementioned method shows clear improvements compared to the actual method of the European Pharmacopoeia, which is less selective and sensitive.
开发了一种用于测定红霉素杂质谱的新型高效液相色谱-紫外检测法。与欧洲药典中描述的液相色谱法不同，该分析可在25℃的温度下进行。红霉素样品在表面带有氰丙基的封端反相柱上进行分析，使用32 mM pH 8.0的磷酸钾缓冲液和乙腈/甲醇（75:25）进行梯度洗脱。与欧洲药典的现行方法相比，上述方法显示出明显的改进，后者的选择性和灵敏度较低。
