Gupta V D, Stewart K R, Gunter J M
J Pharm Sci. 1983 Dec;72(12):1470-1. doi: 10.1002/jps.2600721226.
A spectrophotometric assay method for the quantitative determination of amikacin, kanamycin, neomycin, and tobramycin in pharmaceutical dosage forms has been developed. The method is based on the Hantzsch reaction, forming dihydrolutidine derivatives which can be measured spectrophotometrically. The excipients EDTA, phenol, sodium bisulfite, and sodium citrate do not interfere, while salts of ammonia do interfere. The relative standard deviations based on seven readings were 1.64, 1.88, 2.10, and 1.93% for amikacin, kanamycin, neomycin, and tobramycin, respectively. Assay results have been compared with microbiological assay results provided by the manufacturers. The assay method appears to be stability indicating.
已开发出一种用于定量测定药物制剂中阿米卡星、卡那霉素、新霉素和妥布霉素的分光光度测定法。该方法基于汉茨希反应，形成可通过分光光度法测量的二氢卢剔啶衍生物。辅料乙二胺四乙酸（EDTA）、苯酚、亚硫酸氢钠和柠檬酸钠不产生干扰，而铵盐会产生干扰。基于七次读数的相对标准偏差，阿米卡星、卡那霉素、新霉素和妥布霉素分别为1.64%、1.88%、2.10%和1.93%。已将测定结果与制造商提供的微生物测定结果进行了比较。该测定方法似乎具有稳定性指示作用。
