摘要
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 an HPLC method for the determination of related substances in Tobramycin Eye Drops. Methods An C6H5column（ 250 mm × 4. 6 mm,5 μm） was adopted and the mobile phase A was acetonitrile-water-phosphoric acid（ V ∶ V ∶ V = 5∶ 95∶ 0. 08）,the mobile phase B was acetonitrilewater-phosphoric acid（ V ∶ V ∶ V = 75∶ 25∶ 0. 08）,mobile phase gradient elution program are shown in table 1,The column temperature was 45 ℃ and the wavelength was set at 365 nm. Results Tobramycin and its related substances were completely separated. The average recoveries of related substances deoxystreptaminekanosaminide,neamine,nebramineand and kanamycin B were（ 99. 5 ± 0. 63） %,（ 99. 5 ±0. 67） %,（ 100. 1 ± 0. 51） %,and（ 99. 8 ± 0. 67） %,and the relative standard deviations were 0. 63%,0. 67%,0. 51%,0. 67%,relatively（ n = 9）. Conclusions A specific and sensitive method is developed for the determination of related substances in tobramycin eye drops.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2016年第12期975-980,共6页
Journal of Shenyang Pharmaceutical University
