注射用阿米卡星的含量测定及与0.9%氯化钠注射剂的配伍稳定性考察  

Determination of amikacin in amikacin injection and the compatible stability with 0. 9% sodium chloride injection

作　　者：陈萍[1] 黄滔敏[1] 程能能[1] 

机构地区：[1]复旦大学药学院药理学教研室,上海201203

出　　处：《中国临床药学杂志》2014年第6期376-379,共4页Chinese Journal of Clinical Pharmacy

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339nm；模拟临床用药浓度，将注射用阿米卡星0．6g加入到250mL0．9％氯化钠注射剂中，混合均匀后，在4℃和25℃下考察24h内的含量及pH值，以及观察配伍液的物理变化。结果回归方程为γ=0．5401x＋0．02327，r=0．9991，在0．2～1．5g·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25qC条件下，0～24h配伍液的外观、pH值均无明显变化。4℃条件下24h内配伍液中阿米卡星含量无明显变化，25℃条件下0～12h阿米卡星含量无明显变化，12～24h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24h内稳定，25℃时12h内稳定。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 amikaein 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 mL 0.9% sodium chloride injection. The content of amikacin was deter- mined, and the appearance and pH 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- 1 with a correlation coefficient （r） of 0. 999 1 and a typical re- gression equation was y = 0. 540 1x ＋ 0.023 27. The recovery yields were between 98% - 100% with a RSD value low- er than 3 % （ n = 5 ）. There were no obvious changes in appearance, pH 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℃, thecontent 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℃.

关 键 词：注射用阿米卡星 0.9%氯化钠注射剂 配伍 稳定性 紫外分光光度法 二氢吡啶衍生物 

分 类 号：R927[医药卫生—药学] O657.3[理学—分析化学] R969.3[理学—化学]