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目的:建立使用离子对反相高效液相色谱测定硫酸奈替米星滴眼液含量的方法。方法:采用色谱柱Diamonsil C18柱(250mm×4.6mm,5μm),流动相为乙腈-1.5%磷酸二氢钾(15:85,pH 3.0,含10mmol/L十二烷基硫酸钠),流速0.8mL/min,柱温30℃,检测波长205nm。含量测定用峰面积外标法。结果:硫酸奈替米星在0.1~1.0mg/mL浓度范围内,峰面积与浓度线性关系良好,相关系数r=0.999 8,加样平均回收率为100.1%(RSD=1.16%,n=9)。结论:本法简便,快捷,准确可靠,可用于硫酸奈替米星滴眼液的含量测定。
Objective: To establish a method for the determination of netilmicin sulfate eye drops using ion-pair reversed-phase high performance liquid chromatography. Methods: The column Diamonsil C18 (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-1.5% potassium dihydrogen phosphate (15:85, pH 3.0, containing 10 mmol / L sodium dodecyl sulfate) mL / min, column temperature 30 ℃, detection wavelength 205nm. Determination of peak area with the external standard method. Results: The linear range of peak area was linear with the concentration of netilmycin sulfate in the range of 0.1-1.0 mg / mL, the correlation coefficient was 0.999 8, and the average recoveries were 100.1% (RSD = 1.16%, n = 9 ). Conclusion: This method is simple, rapid, accurate and reliable, and can be used for the determination of netilmicin sulfate eye drops.