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目的:建立以高效液相色谱-蒸发光散射检测器法测定妥布霉素地塞米松滴眼液中妥布霉素含量的方法。方法:色谱柱为VP ODS C18,流动相为1.0%三氟乙酸-甲醇(95∶5),流速为1.0mL·min-1,载气漂移管温度为45℃,压力为3.5bar,检测波长为254nm。结果:妥布霉素检测浓度的线性范围为156.0~436.0μg·mL-1(r=0.999 7);检测限和定量限分别为0.523、1.744μg;平均回收率为99.57%(RSD=0.92%)。结论:本方法准确可靠、专属性强,可用于该制剂的质量控制。
Objective: To establish a method for the determination of tobramycin in tobramycin dexamethasone eye drops by high performance liquid chromatography with evaporative light scattering detector. Methods: The chromatographic column was VP ODS C18 with the mobile phase of 1.0% trifluoroacetic acid-methanol (95: 5) at a flow rate of 1.0 mL · min-1. The carrier gas drift tube temperature was 45 ℃ and the pressure was 3.5 bar. 254 nm. Results: The linear range of the concentration of tobramycin was 156.0 ~ 436.0 μg · mL-1 (r = 0.999 7). The limits of detection and quantification were 0.523 and 1.744 μg, respectively. The average recoveries were 99.57% (RSD = 0.92% ). Conclusion: This method is accurate, reliable and specific. It can be used for the quality control of this preparation.