Stability Analysis of Levofloxacin Hydrochloride and Carbazochrome Sodium Sulfonate in 0.9% Sodium Chloride Injection / 中国药房

ABSTRACT

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=0.9995)and 1.70-34.04 μg/mL for carbazochrome sodium sulfonate(r=0.9998);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.