RP-HPLC法测定帕利百中醋酸泼尼松龙的含量及其有关物质

Determination of the content and the related substances of prednisolone acetate in Poly-Pred by RP-HPLC method

目的 :采用反相高效液相色谱法 ( RP-HPLC)测定帕利百中醋酸泼尼松龙含量及其有关物质。 方法 :采用 ODS柱 ,以水 -乙腈 ( 60∶ 40 )为流动相测定醋酸泼尼松龙的含量 ;以水 -乙腈 ( 69∶ 3 1)为流动相测定醋酸泼尼松龙有关物质的含量 ,均于 2 5 4nm处检测。结果 :醋酸泼尼松龙在质量浓度为 2 4～ 5 6μg/m l范围内呈良好的线性关系 ( r=1.0 0 0 0 ) ,平均回收率为10 0 .0 % ( RSD=0 .4% ,n=6) ,日内 RSD为 0 .4% ( n=6) ,日间 RSD为 0 .3 % ( n=5 )。 结论 :本法简便、快速、准确。

Objective: To determine the content and the related substances of prednisolone acetate in Poly Pred by RP HPLC method. Methods: ODS column and a mixture of water acetonitrile (60∶40) as the mobile phase were used for determination of the prednisolone acetate content and a mixture of water acetonitrile (69∶31) as the mobile phase was used for determination of the related substances. The wavelength for detection was 254 nm. Results:Prednisolone acetate was linear over the range of 24 56 μg/ml ( r =1.000 0). The average recovery was 100.0% (RSD=0.4%, n =6). The within day and between days RSD was 0.4% ( n =6) and 0.3% ( n =5),respectively. Conclusion:The method was simple, rapid, accurate and reliable. [