HPLC测定醋酸泼尼松片中的有关物质  

Determination of the related substances in Prednisone acetate tablet by HPLC

作　　者：韩学静[1] 刘红莉[1] 闫凯[1] 

机构地区：[1]河北省药品检验所,河北石家庄050011

出　　处：《华西药学杂志》2011年第6期597-599,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法测定醋酸泼尼松片的有关物质。方法采用DIONEX Acclaim C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(42∶58),检测波长240 nm。结果泼尼松0.5～30μg.mL-1与峰面积呈良好线性关系(r=0.9999),最低检测限为0.25 ng;醋酸可的松0.5～30μg.mL-1与峰面积呈良好线性关系(r=0.9999),最低检测限为0.25 ng。结论所建方法准确、简便、快速,适用于醋酸泼尼松片的质量控制。OBJECTIVE To determine the related substances in Prednisone acetate tablet by HPLC.METHODS The separation was performed on a DIONEX Acclaim C18 column（250 mm×4.6 mm,5 μm）.The mobile phase was acetonitrile-water（42：58）.The detection wavelength was set at 240 nm.RESULTS The calibration curve of prednisone showed a good linearity over the range of 0.5-30.0 μg·mL-1（r=0.9999）and the LOD was 0.25 ng.The calibration curve of cortisone acetate showed a good linearity over the range of 0.5-30.0 μg·mL-1（r=0.9999）and the LOD was 0.25 ng.CONCLUSION The method is simple,rapid,accurate and suitable for testing the related substances in Prednisone acetate tablets.

关 键 词：醋酸泼尼松片 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]