【摘要】 目的　改进美国药典中尼扎替丁有关物质及含量测定方法的条件。方法　采用等度洗脱法进行测定 ,以甲醇 - 0 .0 5mol·L-1乙酸铵缓冲液 (2 0∶80 )为流动相 ,柱温 30℃ ,检测波长 2 5 4nm ,进样浓度 4 5 0 μg·ml-1,进样量 2 0 μl,流速 1.0ml·min-1。有关物质检查和含量测定同时进行。结果　尼扎替丁在 0 .2 8～ 75 0 μg·ml-1范围内线性关系良好 ,最低检出限为 4 .5ng,高、中、低浓度精密度试验RSD分别为 0 .0 2 %、0 .0 2 %、0 .0 3%。结论　方法简便 ,结果准确。更多还原

【Abstract】 OBJECTIVE To establish an isocratic HPLC method for determining the nizatidine and its related substances.METHODS The mobile phase was a mixture of methanol and buffer solution (20∶80,v/v) with a flow rate of 1.0 ml·min -1.The ultraviolet wavelength was set at 250 nm.The concentration of sample was 450 μg·ml -1,and the injection volume was 20 μl.RESULTS The calibration curve was liner in the range of 0.28-750 μg·ml -1.The minimum detective limit was 4.5 ng,with RSD less than 3%.CONCLUSION The method is simple and accurate.更多还原