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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CLOODS5μm ,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。
In this paper, based on the pharmaco-HPLC chromatographic behavior database and the argument of “peak-to-peak change of pH 4-5 basic drugs”, we optimized the chromatographic conditions on the computer and found a new chromatographic conditions and methods for the determination of famotidine: Column CLO ODS5μm, mobile phase: methanol water triethylamine (20:80:0. 2), adjusted to pH 3-0 with phosphoric acid, detection wavelength: 268 nm, 4-amino-antipyrine as the internal standard In the range of 20 ~ 100 μg / ml, the ratio of peak area (Y) to the concentration (X) showed a good linear relationship with a correlation coefficient of r = 0. 9998, the linear regression equation Y = 0. 00524 + 0. 73121X. The experimental results show that the internal standard can be separated from famotidine and its impurities and degradation products by using the selected mobile phase, which has the advantages of simple operation, simple mobile phase composition, short analysis time, good durability and a chromatographic analysis process min to complete and so on.