RP-HPLC法测定罗氟司特片的溶出度  

Determination of dissolution of roflumilast tablets by RP-HPLC

作　　者：孟咏梅 吴标 柳郁 

机构地区：[1]安徽省皖北药业股份有限公司,宿州234000 [2]合肥久诺医药科技有限公司,合肥230088

出　　处：《北方药学》2015年第2期2-3,共2页Journal of North Pharmacy

摘　　要：目的：建立罗氟司特片溶出度的反相高效液相色谱法测定方法。方法：采用C18色谱柱（150mm×4.6mm,5.0μm）,以水∶乙腈（35∶65）为流动相,检测波长为215nm,柱温25℃,流速1.0ml/min。结果：罗氟司特溶出度测定的线性回归方程为A=425705C-273.88,r=0.9999,线性范围0.0506~0.9104μg/ml。平均回收率为99.77%,RSD为0.25%。结论：该方法操作简便,精密度高,重复性好,可用于罗氟司特片溶出度的测定。Objective：To establish an RP-HPLC method for determining the dissolution of roflumilast tablets. Methods：Stationary phase was Cls （ 150mm×4.6mm, 5.0μm）, with water-aeetonitrile （35：65） as the mobile phase. The detection wavelength was 215nm, column temperature was 25℃, and flow rate was 1.0ml/min. Results：The regression equation of roflumilast was A =425705C-273.88,r=0.9999, which was linear over the range of 0.0506-0.9104μg/ml. The average recovery of Dual aeylate was 99.77%, and RSD was 0.25%. Conclusion：This method is simple, accurate , repeatable and can be used for the dissolution of roflumilast tablets.

关 键 词：RP-HPLC 罗氟司特片 溶出度 

分 类 号：R927.1[医药卫生—药学]