HPLC测定环酯红霉素中的3种杂质

Determination of three kinds of impurities in Erythromy cincyclic 11,12-carbonate by HPLC

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 establish an HPLC method to determine three kinds of impurities in Erythromycin cyclic 11,12-carbonate. METHODS Chromatographic column was Kromasil Eternity-5-C18（ 250 mm × 4. 6 mm,5 μm）,acetonitrile-0. 025mol·L-1diammonium phosphate（ made the p H to 6. 2 with phosphoric acid,and made the p H to 7. 0 with triethylamine）（ 50∶50） was mobile phase,The column temperature was 7 ℃ and the flow velocity was 1. 0 mg·m L^-1. The detection wavelength was 210 nm.RESULTS The three kinds of impuritie in Erythromy cincyclic 11,12-carbonate could be effectively separated from the primary and the concentration among 0. 01-0. 2 mg·m L^-1had a linear relationship with the peak area（ r both of 0. 9999）. The average recoveries were 89. 2%,99. 1%,97. 1%,and the RSD were 2. 62%,2. 81%,0. 82%,respectively. CONCLUSION This method was simple,accurate and reproducible,and could be used for the quality control of Erythromycin cyclic 11,12-carbonate.