琥乙红霉素片含量测定方法的改进

Method Improvement in Content Determination of Erythromycin Ethylsuccinate Tablets

目的:改进琥乙红霉素片剂含量的测定方法。方法:采用高效液相色谱法,以Waters XBridgeTMShied C18(250 mm×4.6 mm,5μm)为色谱柱;0.067 mol.L-1磷酸二氢铵溶液(用三乙胺调节pH至6.5)-乙睛(65∶35)为流动相;检测波长210nm;流速为1.0 ml.min-1;柱温为20℃。结果:红霉素A在39.83～139.41μg.ml-1范围内呈良好的线性关系(r=0.999 3),平均回收率为98.6%(RSD=0.9%,n=9),检测限为1.19μg,定量限为3.58μg。将该法测定结果与效价法测定的含量进行比较,结果基本一致。结论:该方法更简便、准确,重复性好。

Objective： To improve the method for the content determination of erythromycin ethylsuccinate tablets.Method： An HPLC method was applied using analytical column of Waters XBridgeTM Shied C18（250 mm×4.6 mm,5 μm）.The mobile phase consisted of 0.067 mol·L-1 ammonium dehydrogenate phosphate（adjusting pH to 6.5 with diethylamide）-acetonitrile（65∶ 35）.The detection wavelength was 210 nm.The flow rate was 1.0 ml·min-1 and the column temperature was 20℃.Result： There was a good linear relationship within the range of 39.83~139.41 μg·ml-1（r=0.999 3） for erythromycin A.The average recovery was 98.6%（RSD=0.9%,n=9）.The limit of detection and quantitation was 1.19 μg and 3.58 μg,respectively.The results determined by the above method were compared with those by titer method and there was no significant difference.Conclusion： The method is simple,accurate and reproducible.