高效液相色谱法测定红霉素肠溶胶囊的含量

Determination of Erythromycin in Erythromycin Enteric Capsules by HPLC

目的建立测定红霉素肠溶胶囊含量的高效液相色谱法。方法色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为0.067 mol/L磷酸二氢铵溶液(用三乙胺调pH至6.5)-乙腈(58∶42),检测波长为210 nm,流速为1.0 mL/min,柱温为30℃。结果质量浓度线性范围为20～140 g/L(r=0.999 9),平均加样回收率为100.14%,RSD为0.29%(n=6)。结论所用方法简便、准确、灵敏度高、重现性好,可用于红霉素肠溶胶囊的含量测定。

Objective To establish a HPLC method for the determination of erythromycin in erythromycin enteric capsules.Methods The method was performed on Diamonsil C18 column（250 mm×4.6 mm,5 μm）,using 0.067 mol/L NH4H2PO4-acetonitrile（58 ∶42）as the mobile phase with UV detection at 210 nm.The flow rate was 1.0 ml/min and the column temperature was 30 ℃.Results The linear range of hydrochloride was 20-140 g/L（r=0.999 9）,and the average recovery rate was 100.14%with RSD of 0.29%（n=6）.Conclusion The method is simple,accurate,sensitive and reproducible and can be used for the determination of erythromycin in erythromycin enteric capsules.