阿替洛尔片溶出度测定方法的改进  

Improvement of Determination Method of Atenolol Tablets’ Dissolution

作　　者：刘志杰 李东辉 王鑫 LIU Zhijie;LI Donghui;WANG Xin(Beijing Haidian Food and Drug Safety Monitoring Center,Beijing,China 100094)

机构地区：[1]北京市海淀区食品药品安全监控中心,北京100094

出　　处：《中国药业》2019年第20期26-28,共3页China Pharmaceuticals

摘　　要：目的探讨阿替洛尔片溶出度出现不合理高值的原因,并改进其溶出度测定方法。方法采用高效液相色谱法测定,色谱柱为Waters Symmetry C18柱(150 mm×4.6mm,5μm),流动相为磷酸盐缓冲液(取磷酸二氢钾6.8 g,辛烷磺酸钠1.3 g,加水溶解并稀释至1 000 m L,用磷酸调pH至3.0)-甲醇(70∶30,V/V),检测波长为226 nm,柱温为30℃,流速为1.0 m L/min,进样量为20μL。结果阿替洛尔进样量在0.099 4~0.298 2μg范围内与峰面积线性关系良好,平均加样回收率为99.34%,RSD为0.55(n=9);精密度、稳定性、重复性试验结果的RSD均小于1%(n=5)。结论该方法方便、快速、专属性强,可用于测定阿替洛尔片溶出度。Objective To investigate the causes of unreasonable high dissolution of Atenolol Tablets,and to improve the determination method of its dissolution.Methods HPLC was used for the determination.The chromatographic column was Waters Symmetry C18 column(150 mm×4.6 mm,5 μm),the mobile phase was phosphate buffer-methanol(6.8 g of potassium dihydrogen phosphate and1.3 g of sodium octane sulfonate were taken and dissolved in water and diluted to 1 000 m L,the pH was adjusted to 3.0 with phosphoric acid)(70 ∶ 30,V/V),the detection wavelength was 226 nm,the column temperature was 30 ℃,the flow rate was 1.0 m L/min and the sample size was 20 μL.Results The atenolol showed good linear relationship with peak area in the range of 0.099 4-0.298 2 μg.The average recovery was 99.34% and RSD was 0.55(n=9).The RSDs of precision,stability and repeatability test results were all less than 1%(n=5).Conclusion The method is convenient,rapid and specific,which can be used for the determination the dissolution of Atenolol Tablets.

关 键 词：阿替洛尔片 溶出度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]