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p H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20μl。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p H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、1.70~34.04μg/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p H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。
OBJECTIVE：To explore the stability of levofloxacin hydrochloride and carbazochrome sodium sulfonate in 0.9% So- dium 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 levofloxa- cin 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 car- bazochrome 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 carbazo- chrome sodium sulfonate with 0.9% Sodium chloride injection in room temperature is stable within 6 h, they can compatibly use synergistically in clinic.
出处
《中国药房》
CAS
北大核心
2016年第12期1671-1673,共3页
China Pharmacy
