HPLC法测定注射用门冬氨酸阿奇霉素的含量和有关物质

Determination of azithromycin aspartate for injection and its related substances by HPLC

目的建立注射用门冬氨酸阿奇霉素中阿奇霉素的含量和有关物质测定的HPLC法.方法使用Diamonsil C18柱(250mm×4.6mm,10μm),流动相为0.1mol/L磷酸氢二钾(pH9.0):乙腈(55:45),流速1.2ml/min,检测波长210nm,柱温35℃.结果阿奇霉素在浓度0.5～2.5mg/ml内与峰面积呈良好的线性关系,r=0.9997,平均回收率99.52%,RSD为0.65%(n=9).结论该方法简便、准确、专属,可用于注射用门冬氨酸阿奇霉素的含量及有关物质的测定.

Objective To establish an HPLC method for the determination of azithromycin and its (related) substances in azithromycin aspartate for injection. Methods A C_(18) column (Diamonsil, 250mm×4.6mm, 10μm) was used; mobile phase: 0.1mol/L phosphate buffer (pH9.0)∶acetonitrile (55∶45); flow rate: 1.2 ml/min; wavelength: 210nm; the temperature of column: 35℃. Results The linear range for azithromycin was 0.5～2.5mg/ml (r=0.9997). The average recovery of 99.52% was obtained with a RSD of 0.65% (n=9). Conclusion The method is simple, accurate, specific and suitable for the determination of azithromycin and its related substances in azithromycin aspartate for injection.