【摘要】 目的建立衍生化分光光度法测定阿米卡星注射剂中阿米卡星含量,并分析其在0.9%氯化钠注射剂中的稳定性。方法以乙酰丙酮-甲醛为衍生化试剂,硼酸-醋酸为缓冲液,用紫外分光光度法测定,检测波长为339 nm;模拟临床用药浓度,将注射用阿米卡星0.6 g加入到250 m L 0.9%氯化钠注射剂中,混合均匀后,在4℃和25℃下考察24 h内的含量及p H值,以及观察配伍液的物理变化。结果回归方程为y=0.540 1x+0.023 27,r=0.999 1,在0.2~1.5 g·L-1内吸收值与质量浓度呈良好线性关系,加样回收率98%~100%,RSD<3%(n=5);在4℃和25℃条件下,0~24 h配伍液的外观、p H值均无明显变化。4℃条件下24 h内配伍液中阿米卡星含量无明显变化,25℃条件下0~12 h阿米卡星含量无明显变化,12~24 h其含量降低。结论经验证,该方法简便、快速,结果准确、可靠,重复性好,适用于注射用阿米卡星中阿米卡星的含量测定;注射用阿米卡星与0.9%氯化钠注射剂配伍,在4℃时24 h内稳定,25℃时12 h内稳定。更多还原

【Abstract】 AIM To develop a spectrophotometry after direvatization to determine the content of amikacin in amikacin injection and investigate the compatible stability with 0. 9% sodium chloride injection at 4℃ and 25℃.METHODS The UV-spectrophotometry was selected to determine the amikacin based on acetylacetone-foimaldchyde as a derivatized reagent and boric acid-acetic acid as a buffer. The detection wavelength was 339 nm. At 4℃and 25℃,amikacin injection 0. 6 g was added into 250 m L 0. 9% sodium chloride injection. The content of amikacin was determined,and the appearance and p H value of mixture in 24 h were observed. RESULTS A standard curve with excellent linearity was obtained over the range of 0. 2- 1. 5 g·L- 1with a correlation coefficient( r) of 0.999 1 and a typical regression equation was y = 0. 540 1x + 0. 023 27. The recovery yields were between 98%- 100%with a RSD value lower than 3%( n = 5). There were no obvious changes in appearance,p H value and amikacin concentration of mixture within 24 h at 4℃ and 25℃. The content of amikacin changed not obviously within 24 h at 4℃.While at 25℃,the content of amikacin changed not obviously within 0- 12 h and decreased within 12- 24 h. CONCLUSION The method is proved to be accurate,sensitive and reliable and suitable for the quality control of amikacin in amikacin injection. The compatible solution is stable within 24 h at 4℃ and within 12 h at 25℃.更多还原