HPLC测定复方利血平氨苯蝶啶片中利血平的含量

目的: 应用高效液相色谱技术,建立复方利血平氨苯蝶啶片中利血平的含量测定方法。 方法: 采用Alltima C₁₈色谱柱(250 mm×4.6 mm,5 μm),以含0.04%庚烷磺酸钠的50 mmol·L^-1磷酸二氢铵溶液(磷酸调至pH 3.0)－乙腈(48∶ 52,v/v)为流动相,流速0.5 mL·min^-1,检测波长268 nm。 结果: 在本方法中,利血平的线性关系良好, r为0.9999;专属性强,利血平和药品中其它成分以及强制降解产物之间都有良好的分离度;精密度和稳定性良好,RSD均小于2%;加样回收率良好,百分回收率在99.88%~101.4%之间。 结论: 该方法准确、简单、快速,可作为复方利血平氨苯蝶啶片中利血平的含量测定方法。

Objective: To establish an HPLC method for the determination of reserpine in compound hypotensive tablets. Methods: An Alltima C₁₈ column(250 mm×4.6 mm,5 μm)was used for the separation,with 50 mmol·L^-1 ammonium dihydrogen phosphate containing 0.04% heptane sulfonic acid sodium salt (adjusted pH to 3.0 with H₃PO₄)－acetonitrile(48∶ 52,v/v)as the mobile phase at the flow rate of 0.5 mL·min^-1.The detection wavelength was 268nm. Results: The method showed good linearity with a correlation coefficient (r)of 0.9999;the specificity study showed satisfactory resolution between reserpine,other ingredients and forced degradation products;the precision and stability were satisfactory with all RSDs below 2%;and the spiked recovery ranged from 99.01% to 101.92%. Conclusion: This method is an accurate,fast and simple method for the determination of reserpine in compound hypotensive tablets.