HPLC法测定注射用阿奇霉素枸橼酸二氢钠及其有关物质

摘要

Objective To establish an HPLC method for the determination of azithromycin and its related substances in azithromycin sodium dihydrogen citrate for injection.Methods A SHISEIDO CAPCELL PAK C18 MG Ⅱ column(150 mm×4.6mm,5μm)was used; mobile phase: phosphate buffer(0.05 mol/L phosphate buffer adjusted to pH 8.2)- acetonitrile( 45∶55) ; flow rate: 1. 0 mL/min; wavelength: 215 nm; the temperature of column: 35℃.Results The linear range for azithromycin was 0.5~3.0 mg/mL(Y=9.595 62X-0.164 59,r=0.999 9) . The average recovery of 100.2% was obtained with a RSD of 0.7%(n= 9).Conclusion The method is simple, accurate, specific and suitable for the determination of azithromycin and its related substances in azithromycin sodium dihydrogen citrate for injection.%目的：建立注射用阿奇霉素枸橼酸二氢钠中阿奇霉素的含量和有关物质HPLC测定方法。方法使用资生堂C18 MG Ⅱ柱（150 mm×4.6 mm，5μm），磷酸盐缓冲液（0.05 mol/L的磷酸氢二钾，调节pH至8.2）-乙腈（45∶55）为流动相，流速为1.0 mL/min，检测波长215 nm，柱温35℃。结果阿奇霉素在浓度0.5～3.0 mg/mL范围内与峰面积呈良好的线性关系（Y＝9.59562X－0.16459，r＝0.9999），平均回收率为100.2%，RSD为0.7%（n＝9）。结论HPLC法测定注射用阿奇霉素枸橼酸二氢钠及其有关物质，简便、准确、专属性强、重复性好。