HPLC测定复方四环素泼尼松膜中的醋酸泼尼松

Determination of prednisone acetate in Compound tetracycline hydrochloride and prednisone acetate pellicles by HPLC

目的采用HPLC法测定复方四环素泼尼松膜中醋酸泼尼松的含量。方法采用Diamonsil C18色谱柱(250 mm×4.6mm,5μm),甲醇-水(65∶35)为流动相,流速1.0 mL.mim-1,检测波长240 nm。结果 25～250μg·mL-1醋酸泼尼松与峰面积的线性关系良好(r=0.9999),平均回收率为95.06%,RSD=1.14%(n=9)。结论所用方法操作简单、重复性好、测定结果准确,可用于复方四环素泼尼松膜的质量控制。

OBJECTIVE To establish an HPLC method for the determination of prednisone acetate in Compound tetracycline hydrochloride and prednisone acetate pellicles.METHODS HPLC was adopted.Diamonsil C18 column（250 mm×4.6 mm,5 μm） was used with the methanol-water（65：35）as mobile phase.The UV detector was set at 240 nm with a flow rate at 1.0 mL·mim-1.RESULTS The linear range of the method was 25-250 μg·mL-1（r=0.9999）.The average recovery was 95.06% with the RSD of 1.14%（n=9）.CONCLUSION The method is simple,accurate and well reproducible.It can be used for the quality control of Compound tetracycline hydrochloride and prednisone acetate pellicles.