比色法快速测定硫酸卡那霉素注射液的含量

目的:探索硫酸卡那霉素注射液的快速含量测定方法.方法:采用碱性酒石酸铜试剂与硫酸卡那霉素形成有色复合物,比色法测定含量.结果:本法测定波长为max=566±1 nm,回归方程C(万U mL 1)=2.176A 4.311×10 2,r=0.999 3(n=5);线性范围0.21～1.03万U mL 1;4 h内稳定;重现性RSD=0.42%;平均回收率99.7%,RSD=0.79%;含量测定结果与中国药典法基本一致.结论:本法简便、快速、准确,适用于生产单位和医院制剂对该产品的快速质量控制.

Quick Quantitative Determination for Kanamycin in Kanamycin Sulfate Injection

Objective： To explore the quick quantitative method for kanamycin in kanamycin sulphate injection. Methods： Added ATC agent in Kanamycin sulphate solution to make coloring compound and determined it by colorimetric method. Results： The detection was done at λmax, = （566 ±1） nm. The regressive equation was C （10^4U·mL^-1） = 2.176A - 4.311×10^-2, r = 0.999 3 （n = 5） and the concentration linear range was 0.21 × 10^4 - 1.03 × 10^4 U·mL^-1. This method was accuracy （RSD = 0.42 %） and the coloring compound was stable in 4 h. The average recovery rate was 99.7 % （RSD = 0.79 %）. There was no remarkable difference between the results obtained by this method and the Chinese Pharmacopeia method. Conclusion： This method has the advantages of fastness, convenience and accuracy and can be used for the quick quality control in pharmaceutical factory.