建立了系统测定利多卡因肾上腺素注射液中肾上腺素、去甲肾上腺素、亚硫酸肾上腺素及肾上腺素红含量的高效液相色谱-电化学(HPLC-ECD)方法.其中前3种物质用氧化模式分析,肾上腺素红用还原模式分析.优化了电位、流动相pH及离子对试剂含量、灵敏度参数等色谱条件,并对该方法进行了论证:在各物质的线性浓度范围内,该方法显示出良好的线性关系,R2均为0.9999,肾上腺素、去甲肾上腺素、亚硫酸肾上腺素和肾上腺素红的检出限依次为0.27,0.50,0.20,50 μg·L-1,回收率依次为(100.34±0.62)％,(100.16±1.07)％,(100.26±1.21)％,(97.97±0.72)％ (n=9).该方法快速简单、选择性好、灵敏度及准确度高,可用于肾上腺素及其相关物质的分析测定.%An reverse phase high performance liquid chromatography (RP-HPLC) assay coupled with electrochemical detection (ECD) for systematically measuring epinephrine, norepinephrine, epinephrine sulfonate and adrenochrome in lidocaine epinephrine injection was developed. Analyses of epinephrine, norepinephrine and epinephrine sulfonate were conducted in oxidation mode, while adrenochrome was analysed in reduction mode. Chromatographic conditions such as potential, pH and ion-pair reagent content of mobile phase and sensitivity range were optimized. The proposed method was demonstrated strictly. The method shows good linear relationship (R2 = 0. 999 9) in the linear concentration range of four analytes. The detection limit of epinephrine, norepinephrine, epinephrine sulfonate and adrenochrome is 0.27, 0.50, 0.20, 50 μg · L-1, respectively, and the recovery of these substances is (100.34 ± 0.62)%, (100.16±1.07)%, (100.26 ± 1.21)%, (97.97±0.72)% (n=9), respectively. The method is fast and simple and showed high sensitivity, precision, selectivity and recovery, and can thus be used as a quality control method for drugs containing epinephrine and related substances.
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