利用药物HPLC色谱行为数据库优化测定法莫替丁及其降解产物

Optimazational Determination of Famotidine and its Degradation Products by HPLC Behaviour Databases of Drugs

本文利用药物ＨＰＬＣ 色谱行为数据库和“ｐＨ４ ～５ 碱性药物峰序变动区”论点，在计算机上进行色谱条件优化模拟的基础上，寻找到新的测定法莫替丁的色谱条件和方法：色谱柱ＣＬＯＯＤＳ５μｍ ，流动相：甲醇水三乙胺（２０∶８０∶０ ．２） ，用磷酸调ｐＨ 至３－０ ，检测波长：２６８ ｎｍ ，４氨基安替比林为内标物，在所测２０ ～１００ μｇ／ｍｌ 范围内，峰面积之比（Ｙ） 与浓度（Ｘ） 呈良好的线性关系，其相关系数ｒ＝ ０ ．９９９８ ，线性回归方程Ｙ＝ ０ ．００５２４ ＋ ０ ．７３１２１Ｘ。经实验证明：用所选流动相可实现内标与法莫替丁及其杂质和降解产物的基线分离，具有操作简便、流动相组成简单、分析时间短、耐用性好，一次色谱分析过程６ ｍｉｎ 即可完成等优点。

By use of HPLC behaviour databases of drugs and the point of “the elution order reversal region of pH4～5 for basic drugs”,a new method for determination of famotidine has been optimazed.The HPLC was performed on shimpack ODS column and detected at 268nm,with 4 aminoantipyrine as internal standard.The mobile phase consisted of methanol phosphate buffer solution(20:80,pH 3.0).The ruggedness test indicated that baseline separation of internal standard,famotidine and its degration products was reached on 6 different brand columns.The results indicated that this method was easy to operate in shorter time.