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RP-HPLC法测定罗氟司特片的溶出度
引用本文:孟咏梅,吴标,柳郁.RP-HPLC法测定罗氟司特片的溶出度[J].北方药学,2015(2):2-3.
作者姓名:孟咏梅  吴标  柳郁
作者单位:安徽省皖北药业股份有限公司 宿州 234000;合肥久诺医药科技有限公司 合肥 230088
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。

关 键 词:RP-HPLC  罗氟司特片  溶出度

Determination of dissolution of roflumilast tablets by RP-HPLC
Abstract:Objective:To establish an RP-HPLC method for determining the dissolution of roflumilast tablets. Methods:Stationary phase was C18 (150mm×4.6mm,5.0μm),with water-acetonitrile (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 acylate 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.
Keywords:RP-HPLC  Roflumilast  Dissolution
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