尼扎替丁的含量及有关物质测定方法的改进  

An improved method for determining the nizatidine and its related substances

作　　者：张蓉琴[1] 李铜铃[1] 程强[2] 鄢琳[1] 许小红[1] 郑鹏程[1] 

机构地区：[1]四川大学华西药学院,四川成都610041 [2]四川抗菌素工业研究所,四川成都610051

出　　处：《华西药学杂志》2004年第3期217-218,共2页West China Journal of Pharmaceutical Sciences

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。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.

关 键 词：尼扎替丁 测定方法 高效液相色谱法 等度洗脱 

分 类 号：R976[医药卫生—药品]