高效液相色谱法测定阿替洛尔片中阿替洛尔含量及其有关物质

Determination of atenolol and the relevant impurities in atenolol tablets by HPLC

目的 :高效液相色谱法测定阿替洛尔片中阿替洛尔含量及其有关物质。方法 :InertsilODS 3C18(5 μm,4 .6mm×15 0mm)色谱柱 ,磷酸盐缓冲液 甲醇 辛烷磺酸钠 (70 0∶30 0∶1.70 )为流动相 ,检测波长 :2 75nm ,流速 :1.0mL·min-1,柱温 :36℃。结果 :该方法能分离片剂中的阿替洛尔及其相关杂质 ,阿替洛尔在 5 4 .1～ 2 70 .5mg·L-1浓度范围内 ,线性良好 ,r =0 .9999;最低检测限 2 1.6ng。结论 :HPLC法可作为阿替洛尔片的质量控制方法 ,简便快速 。

OBJECTIVE To determine atenolol and the relevant impurities in atenolol tablets by ighperformance liquid chromatography (HPLC).METHODS Inertsil ODS 3 C 18 column ( 5 μm , 4.6 mm × 150 mm ) and phosphate buffer methanol octanesulfnic acid,sodium salt(700∶300∶ 1.70 ) were used as the stationary phase and the mobile phase respectively.The detection wavelength was set at 275 nm ,with the flow rate 1.0 mL ·min -1 and column temperature 36 ℃ .RESULTS The HPLC method can separate atenolol and the relevant impurities in the tablets.The good linearity was obtained over the range of 54.1 - 270.5 mg ·L -1 ( r = 0.999 9 ) with the limit of detection 21.6 ng .CONCLUSION The method is simple,fast,stable and reliable,which can be used as the quality control method for atenolol tablets.