胺碘酮在0.9%氯化钠、5%葡萄糖和木糖醇注射液中的稳定性考察

Compatibility of Amiodarone Hydrochloride Injection in 0. 9% Sodium Chloride,5% Glucose and Xylitol Injection

目的研究盐酸胺碘酮注射液在临床常用3种输液(0.9%氯化钠注射液、5%葡萄糖注射液和木糖醇注射液)配伍溶液中的稳定性。方法采用高效液相色谱(HPLC)法测定盐酸胺碘酮输液剂配伍溶液中不同时间点(5 h内)的含量变化,色谱条件为Agilent TC-C18(2)色谱柱(250 mm×4.6 mm,5μm),流动相甲醇∶三乙胺-磷酸缓冲液(pH 3.2,65∶35,V/V),波长为242 nm,流速1.0 mL·min-1,柱温30℃,并观察其外观性状和pH的变化情况。结果盐酸胺碘酮注射液在0.45~3.6 mg·mL-1浓度范围内的线性关系良好(R2=0.9997),日内RSD值为2.23%,3种盐酸胺碘酮的配伍溶液在不同时间点的pH值、含量及外观性状等比较无显著变化。结论盐酸胺碘酮与0.9%氯化钠注射液、5%葡萄糖注射液和木糖醇注射液配伍后(室温下)5 h内其含量、外观和pH值均无明显变化,其配伍稳定性好。

OBJECTIVE To observe the compatibility of amiodarone hydrochloride injection in mixing 3 kinds of infusions(0.9%sodium-chloride injection,5%glucose injection and xylitol injection).METHODS The contents of amiodarone hydrochloride in mixing 3 kinds of infusions were determined at different time within 5 h by HPLC,the conditions of HPLC were agilent TC-C18(2)analysiscolumn(250 mm×4.6 mm,5μm),mobile phase methanol:triethylamine-phosphate(pH 3.2,65∶35,V/V),flow-rate 1.0 mL·min-1,column temperature 30℃,detection wavelength 242 nm.Moreover the appearance of the solution was observed,and the pH values of compatible solution were determined.RESULTS Amiodarone hydrochloride was liner in the range of amiodarone hydrochloride 0.45-3.6 mg·mL-1(R2=0.9997),the intra-day RSD value was 2.23,the pH value,content and appearance of hydrochloric amiodarone injection with three infusions had no significant change after 5 h at room temperature.CONCLUSION Amiodarone hydrochloric injection remained stable in three kinds of infusions respectively with 5 h.