高效液相色谱法测定原料及片剂中雷尼替丁及其有关物质

• 作 者: 严杏珍
• 出 处: 国外医药.合成药.生化药.制剂分册
• 发表日期: 1990年01期
• 关键词: 有关物质 高效液相色谱法 盐酸雷尼替丁 外标法 糠醇 非水滴定法 定量测定 雷尼 甲硫基 富马酸

本文介绍一种以外标法定量测定原料及片剂中雷尼替丁及其有关物质的高效液相色谱法,此法灵敏,至少可分辨9种有关物质,灵敏度达0.01%以下。经定量测定,原料和片剂含量分别在98.20～101.1%与96.1～102.2%范围内,相对标准偏差小于1%,与非水滴定法比较结果一致。有关化合物有关化合物包括糠醇(1)、(5-二甲胺基甲基)糠醇(2)、富马酸(3)、2(2-氨乙基硫代)甲基-5-(二甲胺基甲基)呋喃(4)、N-甲基-1-甲硫基-2-硝基-1-乙烯胺(5)、1,1-双甲硫基-2-

In this paper, a method for the quantitative determination of ranitidine and its related substances in raw materials and tablets by external standard method is described. The method is sensitive and can detect at least nine related substances with a sensitivity of less than 0.01%. The results showed that the relative standard deviation (RSD) of raw materials and tablets were 98.20 ~ 101.1% and 96.1 ~ 102.2%, respectively. The relative standard deviation was less than 1%, which was consistent with the non-aqueous titration method. Compounds related to the compounds include furfuryl alcohol (1), (5-dimethylaminomethyl) furfuryl alcohol (2), fumaric acid (3), 2 (2-aminoethylthio) Aminomethyl) furan (4), N-methyl-1-methylthio-2-nitro-1-ethenamine (5), 1,1-