硫酸阿米卡星注射液含量的测定方法研究

Study on the Determination of Amikacin Sulfate Injection

目的:建立硫酸阿米卡星注射液的含量测定方法.方法:采用旋光法和抗生素微生物检定法测定硫酸阿米卡星注射液含量.结果:硫酸阿米卡星注射液浓度在1～20 mg/ml范围内与其旋光度呈良好线性关系,回归方程:y=7.892 9x-0.035 6,r=0.999 9,平均回收率98.92 %,RSD为0.42%(n=5).结论:与抗生素法相比旋光法更简便易行,结果准确,可作为该制剂的检验方法.

Objective ：To determine the content of Amikacin Sulfate Injection. Methods： Polarimetric analysis and Antibiotic microorganism was used for determine the content of Amikacin Sulfate Injection. Results：The linear range of Amikacin Sulfate Injection lay between 1-20 mg/ml. The regression equation： C=7.892 9a-0.035 6,r=0.999 9. The average recovery rate was 98.92% with an RSD of 0.42%. Conclusion：Compare width Antibiotic Microbial method, Polarimetry is easy to operate, with accurate and reliable results. It is therefore suitable for the quality control analysis of Amikacin Sulfate Injection.