HPLC-ELSD测定妥布霉素滴眼液的含量

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目的建立高效液相色谱-蒸发光散射检测器检测法(HPLC-ELSD)测定妥布霉素滴眼液的含量。方法选用耐酸性的Agilent Zorbax SB-C18(4.6mm×250mm,5μm)色谱柱;流动相为0.2mol·L-1三氟乙酸溶液-甲醇(92:8),柱温为35℃,流速为0.8mL·min-1,进样体积为10μL;ELSD检测器漂移管温度为45℃,雾化气体压力为3.5bar,信号增益(GAIN)为5。结果妥布霉素在55.6~1396.7μg·mL-1内,其峰面积的对数与浓度的对数呈良好的线性关系(r=0.9997),检测限和定量限分别为0.15μg·mL-1和0.45μg·mL-1。结论方法专属性强,准确可靠,适用于妥布霉素滴眼液产品质量控制。 OBJECTIVE To establish a method for the determination of tobramycin eye drops by HPLC-ELSD with high performance liquid chromatography-evaporative light scattering detector. Methods Acidic Agilent Zorbax SB-C18 column (4.6 mm × 250 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of a 0.2 mol·L-1 trifluoroacetic acid solution (92: 8) 0.8mL · min-1, the injection volume was 10μL; the ELSD detector drift tube temperature was 45 ℃, the atomization gas pressure was 3.5bar, and the signal gain (GAIN) Results The logarithm of the peak area of ​​tobramycin was linear with the logarithm of concentration (r = 0.9997) in the range of 55.6-1396.7μg · mL-1. The limits of detection and quantification were 0. 15μg · mL- 1 and 0.45 μg · mL-1. Conclusion The method is specific, accurate and reliable, suitable for the quality control of tobramycin eye drops.
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