复方利血平片有效成分硫酸双肼屈嗪溶出度检查方法研究

Study on Dissolution Method of Effective Ingredient Compound Reserpine Tablets

目的制定复方利血平片有效成分硫酸双肼屈嗪的溶出度测定方法。方法 HPLC法测硫酸双肼屈嗪的溶出度,采用氰基键合硅胶为填充剂的色谱柱(4.6 mm×250 mm,5μm),流动相为0.01 mol/L庚烷磺酸钠溶液(用20%磷酸调节pH至2.7)-乙腈(70:30);柱温30℃,流速为1.0 mL/min,波长为310 mm。结果硫酸双肼屈嗪在19.8～298.4μg/mL的浓度范围内有良好的线性关系(r=0.998);平均回收率为99.3%,RSD为1.6%。结论此法专属性强,可作为硫酸双肼屈嗪的溶出度测定。

Objective To develop effective ingredient compound reserpine tablets without dihydralazine sulfate,the dissolution test method.Methods HPLC method to measure the dihydralazine sulfate dissolution,using cyano-bonded silica as a filler column（4.6 mm × 250 mm,5 μm）,mobile phase was 0.01 mol/L sodium heptane solution（with 20% phosphoric acid to adjust pH to 2.7）-acetonitrile（70：30）;column temperature 30 ℃,a flow rate of 1.0 mL/min,the wavelength is 310 mm.Results Dihydralazine sulfate in 19.8~298.4 μg/mL concentration range a good linear relationship（r=0.998）;average recovery 99.3%,RSD 1.6% was.Conclusion This method is specific,as the dihydralazine sulfate dissolution test.