注射用卡络磺钠与注射用头孢他啶配伍稳定性考察

Compatible stability of carbazochrome sodium sulfonate injection and ceftazidime for injection by RP-HPLC

目的考察注射用头孢他啶与注射用卡络磺钠在0.9%氯化钠注射液中的配伍稳定性。方法室温[(25±1)℃]下,采用反相高效液相色谱法,以pH 7.0磷酸盐缓冲液∶乙腈(92∶8)为流动相,色谱柱:phe-nomenex Prodigy 5u ODS3 C18柱(150 mm×4.6 mm,5μm),利用二极管阵列检查器,测定不同厂家头孢他啶与卡络磺钠配伍后在0～6 h内的含量变化,同时,观察配伍液外观及pH值变化。结果本试验条件下,0～6 h内配伍液外观、pH值及卡络磺钠、头孢他啶含量变化不明显。结论室温下,注射用头孢他啶与注射用卡络磺钠在0.9%氯化钠注射液中6 h内稳定。

Objective To study the stability and compatibility of carbazochrome sodium sulfonate injection and ceftazidime for injection in 0.9% sodium chloride injection.Methods RP-HPLC method was designed to study the change of content after combination of carbazochrome sodium sulfonate for injection with ceftazidime from different manufactures in 0.9% sodium chloride injection at room temperature[（25±1）℃]within 6 h,the mobile phase was phosphate buffer and acetonitrile（pH=7.0,92∶ 8）,a phenomenex Prodigy 5u ODS C18 column（150 mm×4.6 mm,5 μm）was used,and the appearance was observed,the pH value was determined.Results No significant difference was found in appearance,pH value,the content of carbazochrome sodium sulfonate and ceftazidime in the mixed solution within 6 h.Conclusion The mixture of carbazochrome sodium sulfonate with ceftazidime in 0.9% sodium chloride injection at room temperature were stable within 6 h.