Beaulieu N, Graham S J, Sears R W, Lovering E G
Bureau of Drug Research, Health Protection Branch, Health and Welfare Canada, Tunney's Pasture, Ottawa, Ontario.
J Pharm Biomed Anal. 1989;7(12):1705-9. doi: 10.1016/0731-7085(89)80184-0.
A high-performance liquid chromatographic (HPLC) method has been developed for the determination of famotidine and related compounds in drug raw materials and formulations. The minimum detectable amount of the available related compounds is less than 0.02% and the minimum quantifiable amount is less than 0.1%. Famotidine impurity levels were between 0.5 and 2.5% in raw materials. 0.44% in one tablet sample and about 3% in an IV solution, allowing for stabilizers.
已开发出一种高效液相色谱（HPLC）法，用于测定原料药和制剂中的法莫替丁及相关化合物。现有相关化合物的最低检测量小于0.02%，最低定量限小于0.1%。原料药中法莫替丁杂质水平在0.5%至2.5%之间。一片片剂样品中为0.44%，静脉输液溶液中约为3%（考虑了稳定剂）。
