HPLC-ELSD联用检测干粉吸入剂中硫酸奈替米星的含量

Determination of Netilmicin Sulfate in its dry powder inhalation by HPLC-ELSD

目的采用高效液相色谱-蒸发光散射检测技术,建立了硫酸奈替米星干粉吸入剂中硫酸奈替米星含量的测定方法。方法采用Phenomenex C18柱(5μm,4.6 mm×250 mm)色谱柱;以0.2 mol.L-1三氟乙酸-甲醇(体积比84∶16)为流动相,流速为0.5 mL.min-1;检测器为SHIMADZU ELSD-LTⅡ型蒸发光散射检测器,漂移管温度为40℃,雾化气体压力为350 kPa。结果硫酸奈替米星在进样量为1～40μg范围内线性良好,r=0.999 5,平均回收率为98.96%(RSD=1.98%),样品中其他成分不干扰测定。结论本方法准确、灵敏、重复性好,为硫酸奈替米星干粉吸入剂中硫酸奈替米星含量的测定提供了一种快速、高效的方法。

Objective To develop an HPLC-ELSD method for the determination of Netilmicin Sulfate content in the dry powder inhalation.Methods The separation was performed on a C18（Phenomenex,Gemini,4.6 mm×250 mm,5 μm） with 0.2 mol·L-1 trifluoroacetic acid-methanol（84∶16） as mobile phase.The flow rate was set at 0.5 mL·min-1.The detector was SHIMADZU ELSD-LTⅡ.The temperature of drift tube and gas pressure of the detector was set at 40 ℃ and 350 kPa,respectively.Results The linear range for the injection amount of Netilmicin Sulfate was 1-40 μg,r=0.999 5.The recovery result was 98.96%（RSD=1.98%）.The other ingredients in the sample showed no interference.Conclusion The method was sensitive,accurate and reproducible,which could provide an efficient way for the determination of Netilmicin Sulfate in the dry powder inhalation.