HPLC法测定复方四嗪利血平片中氢氯噻嗪含量.docVIP

HPLC法测定复方四嗪利血平片中氢氯噻嗪含量 　　[摘要] 目的:建立高效液相法测定复方四嗪利血平片中氢氯噻嗪含量的方法。方法:采用Diamonsil-C18(6.0 mm×150 mm,5 μm)色谱柱;流动相:甲醇-水-磷酸盐缓冲液(30∶66∶4)(0.05 mol/L磷酸二氢钾溶液,用磷酸调节pH至3.0);检测波长:272 nm;流速:1.0 ml/min。结果:氢氯噻嗪在0.089 6～0.089 6 μg范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为98.92%,RSD=0.60%(n=6)。结论:本方法简便、准确、重现性好,可用于复方四嗪利血平片中氢氯噻嗪的质量控制。 　　[关键词] 高效液相法;氢氯噻嗪;复方四嗪利血平片;含量测定 　　[中图分类号] R927.2[文献标识码]A [文章编号]1673-7210(2010)02(b)-055-02 　　 　　Content determination of hydrochlorothiazide in Compound Tatrazin and Reserpine Tablets by HPLC 　　CHEN Yupu 　　(Institute for Food and Drug Control of Jiaozuo City, Jiaozuo 454000, China) 　　[Abstract] Objective: To establish a method for the content determination of hydrochlorothiazide in Compound Tatrazin and Reserpine Tablets by HPLC. Methods: The Diamonsil-C18 (6.0 mm×150 mm, 5 μm) column was used. The mobile phases consisted of methanol, water and phosphate buffer solution (30∶66∶4) [adjust Potassium dihydrogen phosphate, Solution (0.05 mol/L) to pH=3.0 by phosphoric acid], the flow rate was 1.0 ml/min and the detection wavelength was at 272 nm. Results: The linear ranges of hydrochlorothiazide was at 0.089 6-0.089 6 μg (r=0.999 9), the average recovery was 98.92% with a RSD of 0.60% (n=6). Conclusion: The method is fast, reliable, accurate and can be used in the quality control of hydrochlorothiazide in Compound Tatrazin and Reserpine Tablets. 　　[Key words] HPLC; Hydrochlorothiazide; Compound Tatrazin and Reserpine Tablets; Content determination 　　 　　复方四嗪利血平片为常用降压药品,主要成分为利血平和氢氯噻嗪,其中氢氯噻嗪有利尿、降压等作用。复方四嗪利血平片现行国家药品标准中氢氯噻嗪只做定性鉴别,无含量测定。 本实验建立用高效液相色谱法测定其中氢氯噻嗪的含量,作为复方四嗪利血平片质量控制指标之一,为控制药品质量,提供了一种简单、灵敏、快速准确的检测方法。 　　1 仪器与试药 　　1.1 仪器 　　UVIKONXL型紫外分光光度计(法国);AE-240双量程电子天平(瑞士梅特勒公司);岛津高效液相色???仪(LC-10ADVP泵;SPD-10AVP紫外检测器;CS-Light Potrun Analysis数据处理系统)。 　　1.2 试药 　　氢氯噻嗪对照品(批号:10309-0001,中国药品生物制品检定所,供含量测定用,含量为99.40%);复方四嗪利血平片(批号:080317,郑州邦泰药业有限公司;批号:080102,新乡中杰药业有限公司;批号郑州海缔邦林制药有限公司);水为纯净水,甲醇为一级色谱纯。 　　2 方法与结果 　　2.1 色谱条件 　　色谱柱:Diamonsil-C18(6.0 mm×150 mm,5 μm