复方硫酸双肼屈嗪片的含量均匀度考察

目的:建立复方硫酸双肼曲嗪的含量均匀度方法,评价药品质量。方法:采用Aglient Eclipse XDB-CN柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.01 mol·L-1庚烷磺酸钠溶液(用20%磷酸调节pH至2.7)(55∶45),流速为0.8 mL·min-1,检测波长316 nm。结果:硫酸双肼屈嗪在34.38～343.8 mg·L-1的范围内线性关系良好(r=0.9999,n=6),测得平均回收率为100.1%(RSD=0.70%);氢氯噻嗪在25.70～257.0 mg·L-1的范围内线性关系良好(r=0.9999,n=6),测得平均回收率为100.9%(RSD=0.33%)。结论:本方法简便、快速,专属性强,可用于复方硫酸双肼屈嗪片的质量控制。

Investigation of the content uniformity of compound dihydralazine sulfate tablets

Objective:To establish the method for content uniformity of compound dihydralazine Sulfate Tablets and evaluate the quality.Methods:The HPLC column was Aglient Eclipse XDB-CN column(250 mm×4.6 mm,5 μm);the mobile phase was acetonitrile-0.01 mol·L-1 Sodium Heptanesulfonate solution(adjust to pH 2.7 with 20% phosphoric Acid solution)(55∶ 45);the flow rate was 0.8 mL·min-1,the detection wavelength was 316 nm.Results:The linear range of Dihydralazine Sulfate was 34.38-343.8 mg·L-1(r=0.9999,n=6),the average recovery rate was 100.1%(RSD=0.70%).The linear range of Hydrochlorothiazide was 25.70-257.0 mg·L-1(r=0.9999,n=6),the average recovery rate was 100.9%(RSD=0.33%).Conclusion:The method is convenient,accurate,simple and feasible.It can be used as a method of quality control.