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目的采用HPLC法测定环酯红霉素中的3种杂质。方法色谱柱为Kromasil Eternity-5-C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.025 mol·L-1磷酸氢二铵溶液(磷酸先调p H6.2,再用三乙胺调p H7)(50∶50),柱温7℃,流速1.0m L·min-1,检测波长210 nm。结果环酯红霉素中3种杂质的分离较好,与主峰均能有效分离,线性范围为0.01~0.2 mg·m L-1(r=0.9999);3种杂质的平均回收率分别为89.2%、99.1%、97.1%,RSD分别为2.62%、2.81%、0.82%。结论所用方法简便、准确、重复性好,可用于环酯红霉素的质量控制。
OBJECTIVE To determine the three impurities in erythromycin by HPLC. Methods The column was Kromasil Eternity-5-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.025 mol·L-1 diammonium phosphate solution (phosphoric acid was first adjusted to p H6.2, Amine transfer p H7) (50:50), the column temperature 7 ℃, flow rate 1.0m L · min-1, detection wavelength 210 nm. Results The separation of three impurities in cyclo-ester erythromycin was better and the main peak could be effectively separated with a linear range of 0.01-0.2 mg · mL -1 (r = 0.9999). The average recoveries of the three impurities were 89.2 %, 99.1%, 97.1%, RSD respectively 2.62%, 2.81%, 0.82%. Conclusion The method is simple, accurate, reproducible and can be used for the quality control of erythromycin.