小剂量吲达帕胺片的质量标准  

Quality Criteria of Small Dose of Indapamide

作　　者：石云龙[1] 孟祥军[2] 刘志梅 

机构地区：[1]沈阳医学院沈洲医院,沈阳市和平区北九马路20号110035 [2]沈阳医学院化学教研室 [3]辽宁卫生职业技术学院药学系,沈阳市苏家屯区乔松路2号110101

出　　处：《光谱实验室》2012年第5期2967-2973,共7页Chinese Journal of Spectroscopy Laboratory

摘　　要：对已设计的吲达帕胺片剂处方进行筛选、工艺优化,并建立高效液相色谱法进行吲达帕胺片剂的有关物质检测。采用Hypersil ODS2(200mm×4.6mm,5μm)色谱柱,流动相为冰乙酸-乙腈-甲醇-0.2g/L EDTA二钠(0.1∶20∶20∶60,V/V/V/V),流速为1.0mL/min,检测波长为254nm,柱温为40℃。有关物质的检查方法完善了现版《中国药典》标准的色谱系统,更准确地进行杂质分析及限量,专属性强,可满足吲达帕胺片剂的有关物质测定。The designed prescription of indapamide tablet was screened,the technology was optimized,and the method for detection of the relevant substance of indapamide tablet by HPLC was established.The compound was separated by Hypersil ODS2 column（200mm×4.6mm,5μm） with the mobile phase of glacial acetic acid∶acetonitrile∶methanol∶0.2g/L EDTA-2Na（0.1∶20∶20∶60,V/V/V/V） at the flow rate of 1.0mL/min,the detection wavelength was 254nm,and the column temperature was 40℃.The detection method for the relevant substance perfected the chromatographic system of china pharmacopeia standard,which can better analyze and limit the relevant substance with strong specificity,and can meet the determination of the relevant substance of indapamide.

关 键 词：吲达帕胺片 高效液相色谱法 有关物质 

分 类 号：O657.72[理学—分析化学]