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目的建立高效液相色谱-蒸发光散射检测法测定硫酸阿米卡星含量,并与微生物法测定结果进行比较。方法采用Phenomenex C_18色谱柱,流动相为0.2mol/L三氟乙酸-甲醇(85:15),流速0.8ml/min,漂移管温度110°C,氮气流速3L/min,进样体积20μl。结果蒸发光散射法测定的方法学结果表明,在0.05～0.23mg/ml浓度范围内线性关系良好(r=0.9999)。三批硫酸阿米卡星注射剂含量的结果为88.61±2.8%、90.82±1.5%和92.32±0.4%。采用微生物法测定的结果为88.94±1.8%、90.88±1.2%和93.11±1.6%。结论所建立的蒸发光散射法测定硫酸阿米卡星注射剂具有快速简单准确的特点。
OBJECTIVE To establish a method for the determination of amikacin sulfate by high performance liquid chromatography-evaporative light scattering and to compare with the results of microbial assay. Methods Phenomenex C18 column was used. The mobile phase was 0.2mol / L trifluoroacetic acid-methanol (85:15), the flow rate was 0.8ml / min, the drift tube temperature was 110 ° C, the flow rate of nitrogen was 3L / min and the injection volume was 20μl. Results The methodological results of evaporative light scattering showed that there was a good linear relationship (r = 0.9999) in the concentration range of 0.05 ~ 0.23mg / ml. The results for the three batches of amikacin sulfate injection were 88.61 ± 2.8%, 90.82 ± 1.5% and 92.32 ± 0.4%. The results of the microbiological assay were 88.94 ± 1.8%, 90.88 ± 1.2% and 93.11 ± 1.6%. Conclusion The established evaporative light scattering method is rapid, simple and accurate for the determination of amikacin sulfate injection.