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目的:建立高效液相色谱-蒸发光散射检测器(HPLC-ELSD)检测法测定阿米卡星洗剂的含量。方法:采用Agilent ZORBAX Extend-C18(4.6mm×250mm,5μm)碱性色谱柱,流动相为水-氨水-冰醋酸(96∶3.6∶0.4,用氨水或冰醋酸调节pH至10.0),流速为1.0mL·min-1,漂移管温度为50℃,雾化气体压力为3.5×105Pa。结果:阿米卡星和主要杂质K29分离良好。阿米卡星在0.6～6.0mg·mL-1的浓度范围内呈较好的线性关系(r=0.9999),阿米卡星的平均回收率(n=9)为100.2%。结论:方法快速、简便,结果准确可靠,重复性好。
Objective: To establish a high performance liquid chromatography - evaporative light scattering detector (HPLC-ELSD) assay for the determination of amikacin lotion. METHODS: A basic column of Agilent ZORBAX Extend-C18 (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was water-ammonia-glacial acetic acid (96: 3.6: 0.4, adjusted to pH 10.0 with ammonia or glacial acetic acid) 1.0mL · min-1, drift tube temperature of 50 ℃, atomizing gas pressure of 3.5 × 105Pa. Results: Amikacin was separated well from the major impurity K29. Amikacin has a good linear relationship (r = 0.9999) in the concentration range of 0.6-6.0 mg · mL-1, and the average recovery of amikacin (n = 9) was 100.2%. Conclusion: The method is rapid, simple, accurate, reliable and reproducible.