吲哒帕胺及片剂有关物质研究  

Determination of related substances in indapamide tablets by HPLC

作　　者：赵喆[1] 唐素芳[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2010年第3期1-3,共3页Tianjin Pharmacy

摘　　要：目的:建立了吲哒帕胺及片剂有关物质色谱系统适用性试验。方法:色谱柱为Sepax Sapphire C18(4.6mm×250mm,5μm);流动相为甲醇-水-冰醋酸(45∶55∶0.1);流速为1.0ml/min;检测波长为240nm;进样量为20μl。结果:该方法完善了现版《中国药典》标准的色谱系统,提高了HPLC的专属性。结论:本方法准确、适用性强,可满足吲哒帕胺及片剂的有关物质测定。Objective：To establish a system suitability test for the determination of related substances in indapamide and its tablets by HPLC.Method：The chromatographic column was Sepax SapphireC18（4.6 mm×250 mm,5 μm）,and the mobile phase consisted of methanol-water-acetic acid（45∶55∶0.1）,the flow rate of which was 1.0 ml/min.The sample was injected into the chromatograph with a volume of 20 μl and indapamide was detected at the wavelength of 240 nm.Conclusions：The suitability and specificity of the chromatographic system were improved,and the new method was both accurate and suitable for determination of the related substances in indapamide tablets.

关 键 词：吲哒帕胺 片剂 有关物质 

分 类 号：R972.4[医药卫生—药品]