HPLC法测定醋酸地塞米松片有关物质

目的建立HPLC法测定醋酸地塞米松片中有关物质。方法采用HPLC法,C18柱(250mm×4.6mm,5μm);流动相:乙腈-水(40:60);流速:1.0mL/min;检测波长240nm。结果有关物质的浓度在0.50～12.56μg/mL范围内,与峰面积呈良好的线性关系(r=1),醋酸地塞米松与其有关物质能有效分离,有关物质的最低检出限(S/N=3)为10ng/mL。结论采用HPLC法测定醋酸地塞米松片的准确率高、专属性强,可用于该药有关物质的检查。

HPLC determination of relative substances in dexamethasone acetate tablets

Objective A method for the determination of relative substances in Dexamethasone Acetate Tablets was established.Methods CAPCEL PAK C18 column(250 mm×4.6 mm,5 μm);Acetonitrile-water(40:60)as the mobile phase;the flow rate was 1.0 mL/min,detecting wavelength was 240 nm.Results The linear range of relative substances was 0.50 ～ 12.56 μg/mL(r=1),Dexamethasone Acetate and relative substances could be effectively separated,the lowest detection limit of relative substance(S/N=3)was 10ng/mL.Conclusion The method was accurate,simple and specific.It may be adopted for the examination of the impurities of the drug.