复方硫酸双肼屈嗪片含量测定方法的改进

目的:建立高效液相色谱法同时测定复方硫酸双肼屈嗪片中硫酸双肼屈嗪和氢氯噻嗪的含量.方法:采用Aglient E-clipse XDB-CN柱(4.6 mm × 250 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),流量为0.8 mL·min-,检测波长316 nm.结果:硫酸双肼屈嗪在34.38～ 343.8 mg·L-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.

Improvement of Test Method on Assay of Compound Dihydralazine Suffate Tablets

Objective： To establish an HPLC method for determination of Compound Dihydralazine Sulfate Tablets. Methods： The HPLC column was Aglient Eclipse XDB-CN column（4. 6 mm× 250 mm,5 μm） ;the mobile phase was aeetonitrile-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.