西咪替丁及其有关物质的反相HPLC测定

Determination ofcimetidine and its related substances by RP HPLC

采用反相高效液相色谱法， 以甲醇－ 水－ 磷酸（ 体积比１７０∶８３０∶２） 为流动相， 甲硝唑为内标， 测定西咪替丁含量； 以３００ｍＬ甲醇、０－３ｍＬ磷酸、９４０ｍｇ 己基磺酸钠， 加水至１０００ｍＬ为流动相， 测定西咪替丁中有关物质的含量。该法可使西咪替丁与甲硝唑及有关物质间达到良好的分离， 重现性试验ＲＳＤ为０－５％ （ｎ ＝８）。操作简便， 结果准确、可靠。

A RP HPLC method for the determination of cimetidine and its related substances was established The mobile phase for cimetidine was composed of methanol,water and phosphoric acid (the volume ratio was 170∶830∶2),and that for related substances was consisted by 300mL methanol, 0 3 mL phosphoric acid,940mg sodium hexyl sulphonate and added water to 1000mL The internal standard agent was metronidagole The RSD of the replicate tests was 0 5%( n =8) By this method,the cimetidine,metronidagole and its related substances could be separated well,the operation was simple and the results were accurate