盐酸坦索罗辛缓释微丸有关物质测定方法的探讨  

Discussion on the Determination of Related Substances of Tamsulosin Hydroloride Sustained Release Pellets

作　　者：董煜 于本涛 钱小平 

机构地区：[1]大连市药品检验所,大连116021

出　　处：《中国药品标准》2015年第1期24-27,共4页Drug Standards of China

摘　　要：目的:建立HPLC测定盐酸坦索罗辛缓释微丸有关物质的方法。方法:采用DikmaTechnologies C_(18)(4.6 mm×150 mm,5μm)柱,以高氯酸溶液.乙腈(70:30)为流动相,流量1.0 mL·min^(-1),检测波长225nm,柱温40 oC,采用主成分自身对照法测定有关物质。结果:线性范围为0.02~0.12μg·mL^(-1)(r=0.999 3),最低检测限为2 ng,有关物质各杂质峰与主峰之间的分离度良好。结论:本方法准确、简便,专属性强,可用于盐酸坦索罗辛缓释微丸的药品质量控制。Objective： To establish an HPLC method for the determination of related substances of Tamsulosin Hydroloride Sustained Release Pellets. Method： Dikma Technologies Cls column（4. 6 mm× 150mm,5μm）was used at 40 ℃. The mobile phase consisted of perchloric acid bufferand acetonitrile （70： 30） at flow rate of 1.0 mL · min^-1 and the detection wavelength was set at 225 nm. Results： The linear range of the method was 0.02 -0. 12 μg · mL^-1 （r =0. 999 3）and the LOD was 2 ng. Conclusion： The method for the determination of related substances of Tamsulosin Hydroloride SustainedRelease Pellets is rapid, specific and accurate.

关 键 词：盐酸坦索罗辛缓释微丸 高效液相色谱法 有关物质 

分 类 号：R921.2[医药卫生—药学]