盐酸胺碘酮注射液与4种临床常用输液的配伍稳定性考察  

Compatible stability of amiodarone hydrochloride injection with four kinds of infusion fluids

作　　者：梁卉[1] 胡乔乔[2] 谭爱萍[1] 

机构地区：[1]大连医科大学附属第一医院药剂科,大连116011 [2]大连医科大学药学院,大连116044

出　　处：《实用药物与临床》2011年第3期231-233,共3页Practical Pharmacy and Clinical Remedies

摘　　要：目的考察盐酸胺碘酮注射液与临床常用4种输液(5%葡萄糖注射液、10%葡萄糖注射液、葡萄糖氯化钠注射液及0.9%氯化钠注射液)的配伍稳定性。方法采用Hypersil BDS-C18色谱柱(250 mm×4.6mm,5μm),甲醇∶磷酸-三乙胺缓冲液(pH3.2)(65∶35,V/V)为流动相,柱温30℃,流速1.0 mL/min,检测波长242 nm,测定盐酸胺碘酮注射液与上述4种输液在室温下配伍后6 h内不同时间的含量变化,并观察溶液外观性状及pH值的变化。结果本实验所建立的色谱条件对盐酸胺碘酮的检测专属性好,配伍液中盐酸胺碘酮在0.15～2.4 mg/mL浓度范围内,线性关系良好(R2=1),日内RSD值为0.01%,4种配伍液在6 h内峰面积均无明显变化,RSD值均小于2.0%。结论盐酸胺碘酮注射液与4种输液在室温下配伍后6 h内含量、pH值、外观无明显变化,体外配伍稳定。Objective To investigate the compatible stability of amiodarone hydrochloride injection in 4 kinds of infusions（5% glucose injection,10% glucose injection,5%glucose in 0.9% sodiumchloride injection,0.9% sodiumchloride injection）.Methods The contents of amiodarone hydrochloride were determined at different time within 6h by HPLC after mixing with 4 kinds of infusions,the appearance of the solution was observed,and the pH value of compatible solution were determined.HPLC was performed on hypersil C18 analysis column（250 mm×4.6 mm,5 μm）with methanol∶phosphate-triethylamine buffer（pH 3.2）（65∶35,V/V）as mobile phase at flow-rate of 1.0 mL/min,column temperature was 30 ℃.The detection wavelength was 242 nm.Results Compatibility in liquid hydrochloric acid amiodarone was linear in the range of amiodarone hydrochloride 0.15～2.4 mg/mL（R2=1）,The intra-day RSD was less than 0.01%.The contents（RSD2%）,pH value,appearance of hydrochloric amiodarone injection with four infusions had no change after 6 h at room temperature.Conclusion Hydrochloric amiodarone injection is stable in four kinds of infusions respectively within 6 h.

关 键 词：盐酸胺碘酮注射液 高效液相色谱法 配伍 稳定性 

分 类 号：R942[医药卫生—药剂学]