盐酸左氧氟沙星与卡络磺钠在0.9%氯化钠注射液中的稳定性考察
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篇名: 盐酸左氧氟沙星与卡络磺钠在0.9%氯化钠注射液中的稳定性考察
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摘要: 目的:探讨盐酸左氧氟沙星与卡络磺钠在0.9%氯化钠注射液中混合的稳定性,以期为二者的临床配伍使用提供一定的参考。方法:采用高效液相色谱法同时测定。色谱柱为Phenomenex Gemini C18,流动相A为乙腈、流动相B为0.01 mol/L磷酸二氢铵溶液(用磷酸调pH至3.0)(采用梯度洗脱),流速为1.0 ml/min,检测波长为295 nm(盐酸左氧氟沙星)、364 nm(卡络磺钠),柱温为35 ℃,进样量为20 μl。考察二者在0.9%氯化钠注射液中混合后的含量、外观和溶液pH值的变化。结果:盐酸左氧氟沙星、卡络磺钠检测质量浓度线性范围分别为7.03~80.06、1.70~34.04 μg/ml(r=0.999 5、0.999 8);精密度、重复性试验的RSD<2.0%;加样回收率分别为98.75%~100.63%、98.00%~100.83%,RSD分别为0.65%、0.99%(n=9);二者在0.9%氯化钠注射液中混合后常温放置6 h内,含量未见明显降低,混合溶液外观和pH值未见明显变化。结论:盐酸左氧氟沙星与卡络磺钠在0.9%氯化钠注射液中混合后,室温放置6 h内较稳定,临床可协同配伍使用。
ABSTRACT: OBJECTIVE:To explore the stability of levofloxacin hydrochloride and carbazochrome sodium sulfonate in 0.9% Sodium chloride injection, and provide reference for their compatible use in clinic. METHODS:HPLC was performed on the column of Phenomenex Gemini C18 with mobile phase A of acetonitrile and B of 0.01 mol/L Ammonium biphosphate solution (adjusted to pH 3.0 with phosphoric acid) (gradient elution) at a flow rate of 1.0 ml/min, the detection wavelength was 295 nm for levofloxacin hydrochloride and 364 nm for carbazochrome sodium sulfonate, temperature was 30 ℃, and the injection volume was 20 μl. The changes of contents, appearance and pH value of the solution in the mixture were investigated. RESULTS:The linear range was 7.03-80.06 μg/mL for levofloxacin hydrochloride(r=0.999 5) and 1.70-34.04 μg/mL for carbazochrome sodium sulfonate(r=0.999 8);RSDs of precision and reproducibility tests were no more than 2.0%;recoveries were 98.75%-100.63% and 98.00%-100.83%, and RSDs were 0.65% and 0.99%(n=9), respectively. In normal temperature, the contents of levofloxacin hydrochloride and carbazochrome sodium sulfonate after mixing with 0.9% Sodium chloride injection within 6 h showed no significant decrease, and the appearance and pH value showed no obvious changes. CONCLUSIONS:The mixing of levofloxacin hydrochloride and carbazochrome sodium sulfonate with 0.9% Sodium chloride injection in room temperature is stable within 6 h, they can  compatibly use synergistically in clinic.
期刊: 2016年第27卷第12期
作者: 魏秀美
AUTHORS: WEI Xiumei
关键字: 高效液相色谱法;盐酸左氧氟沙星;卡络磺钠;0.9%氯化钠注射液;稳定性
KEYWORDS: HPLC; Levofloxacin hydrochloride; Carbazochrome sodium sulfonate; 0.9% Sodium chloride injection; Stability
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