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目的建立测定妥布霉素滴眼液有关物质的HPLC方法。方法色谱柱为苯基柱(250 mm×4.6 mm,5μm);以水-乙腈-磷酸(体积比为95∶5∶0.08)为流动相A,以水-乙腈-磷酸(体积比为25∶75∶0.08)为流动相B,采用梯度洗脱;检测波长为365 nm;柱温为45℃。结果在选定色谱条件下妥布霉素与各有关物质均能得到良好分离,有关物质妥布霉素A、新霉胺、尼伯胺和卡那霉素B的平均回收率分别为(99.5±0.63)%、(99.5±0.67)%、(100.1±0.51)%、(99.8±0.67)%,相对标准偏差分别为0.63%、0.67%、0.51%、0.67%(n=9)。结论该方法专属性强,可用于妥布霉素滴眼液有关物质的测定。
Objective To establish HPLC method for the determination of tobramycin eye drops related substances. Methods The mobile phase A was water-acetonitrile-phosphoric acid (volume ratio: 95: 5: 0.08) 75:08) as mobile phase B, using gradient elution; detection wavelength was 365 nm; column temperature was 45 ℃. Results The results showed that tobramycin was well separated from all related substances under the selected chromatographic conditions. The average recoveries of tobramycin A, neotamix, nepamine and kanamycin B were (99.5 ± 0.63%, 99.5 ± 0.67%, 100.1 ± 0.51% and 99.8 ± 0.67% respectively. The relative standard deviations were 0.63%, 0.67%, 0.51% and 0.67%, respectively. Conclusion This method is specific and can be used for the determination of related substances in tobramycin eye drops.