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目的建立测定注射液中硫酸阿米卡星的新方法。方法采用高灵敏度的化学发光分析法,结合流动注射技术,测定药物制剂中硫酸阿米卡星的含量。通过单因素试验和正交试验对鲁米诺、高锰酸钾及氢氧化钠3因素进行优化。结果该化学发光体系的最优条件:鲁米诺溶液浓度为5.0×10~(-4) mol·L~(-1)、高锰酸钾溶液浓度为1.0×10~(-5) mol·L~(-1)、氢氧化钠浓度为0.1 mol·L~(-1)。硫酸阿米卡星浓度在1.0×10~(-8)~1.0×10~(-6) g·mL~(-1)内与相对化学发光强度成良好线性关系,相关系数为0.991 7,检出限为7.5×10~(-9) g·mL~(-1)。在体系最佳条件下,对浓度为1.0×10~(-7) g·mL~(-1)的硫酸阿米卡星溶液平行测定11次,RSD为2.4%,回收率均>96%。结论该法简便快速,结果准确可靠,可用于注射液中硫酸阿米卡星的含量测定。
Objective To establish a new method for the determination of amikacin sulfate in injection. Methods Highly sensitive chemiluminescence analysis and flow injection technique were used to determine the content of amikacin sulfate in the drug formulation. Three factors of luminol, potassium permanganate and sodium hydroxide were optimized by single factor test and orthogonal test. Results The optimal conditions of the chemiluminescence system were as follows: the concentration of luminol solution was 5.0 × 10 -4 mol·L -1 and the concentration of potassium permanganate solution was 1.0 × 10 -5 mol · L ~ (-1) and the concentration of sodium hydroxide was 0.1 mol·L ~ (-1). The concentration of amikacin sulfate showed a good linear relationship with the relative chemiluminescence intensity in the range of 1.0 × 10 -8 to 1.0 × 10 -6 g · mL -1 with a correlation coefficient of 0.991 7 The limit was 7.5 × 10 ~ (-9) g · mL -1. Under the optimal conditions, the average concentration of amikacin sulfate was 1.0 × 10 ~ (-7) g · mL ~ (-1), and the RSD was 2.4% with the recovery of 96%. Conclusion The method is simple and rapid, the results are accurate and reliable, and can be used for the determination of amikacin sulfate in injection.