阿替洛尔及其片剂有关物质检查法的改进  

Improvement of Related Substances Test Method for Atenolol and Atenolol Tablets

作　　者：刘红莉[1] 曹凤习[1] 赫晓军[1] 马钱钱[2] 

机构地区：[1]河北省药品检验所,石家庄050011 [2]山西长治医学院,长治046000

出　　处：《中国药品标准》2009年第5期380-382,共3页Drug Standards of China

摘　　要：目的:改进阿替洛尔及阿替洛尔片有关物质的测定方法。方法:采用HPLC法,色谱柱为十八烷基硅烷键合胶,以磷酸盐缓冲液(取磷酸二氢钾6.8g,加水溶解并稀释至1000mL,用磷酸调节pH值至3.0)700mL,加甲醇300mL与辛烷磺酸钠1.30g,混匀,作为流动相;检测波长为226nm;流速为1.0mL·min-1。结果:本方法准确、可靠。结论:改进后的质量标准可更有效地控制产品的质量。Objective： To improve the related substances tests for Atenolol and Atenolol Tablets. Method： High performance liquid chromatography was carried out （Appendix V D）, using a column packed with octadecylsilanee silica gel and a mixture of 700 mL of phosphate BS （ dissolve 6.8g of potassium dihydrogen phosphate with water and dilute to 1 000 mL, adjust the pH to 3.0 with phosphoric acid） ,300 mL of methanol and 1.30g of sodium octanesuffonate as the mobile phase. Detection wavelength was set at 226 nm. The flow rate was 1.0 mL · min^ - 1 . Results ： This method is accruate and reliable. Conclusions ： The improving quality standards can control the qulity of this product effectively.

关 键 词：检测波长 阿替洛尔及其片剂 有关物质 

分 类 号：R972.4[医药卫生—药品] R972[医药卫生—药学]