高效液相色谱法同时测定复方盐酸左氧氟沙星眼用温敏凝胶中三种组分的含量

Simultaneous Determination of Three Components in Compound Levofloxacin Hydrochloride Thermosensitive Ophthalmic Gels by High Performance Liquid Chromatography

目的建立高效液相色谱法测定复方盐酸左氧氟沙星眼用温敏凝胶制剂中3种组分的含量。方法采用高效液相色谱法,以Sh im-pack VP-ODS柱（4.6 mm×250 mm,5μm）做分析柱,以甲醇-0.025 mol/L KH2PO4缓冲液（55∶45;用25%的H3PO4调pH=4.5）为流动相,流速：1.0 m l/m in,柱箱温度：40℃,紫外检测波长：241 nm。结果盐酸左氧氟沙星、地塞米松磷酸钠、对羟基苯甲酸乙酯线性范围分别为8.56137.20、1.2520.00、0.7512.00μg/ml（r=0.9999,n=5）,高、中、低3个浓度的平均加样回收率分别为100.92%、102.14%、101.29%。3种组分精密度和重复性的RSD均小于1.00%。结论本文建立的高效液相色谱法用于复方盐酸左氧氟沙星温敏凝胶的含量测定,快速、准确、可行。

Objective To establish an high performance liquid chromatography method for the determination of three components in compound levofloxacin hydrochloride thermosensitive ophthalmic gels.Mehtods The high performance liquid chromatography method was used with Shim-pack VP-ODS column（4.6 mm×250 mm,5 μm）.The mobile phase consisted of methanol and 0.025 mol/L potassium dihydrogen phosphate solution（55∶45;adjusted pH=4.5 with 25% H3PO4）,at the flow rate of 1.0 ml/min.The temperature of column was at 40℃.The detection wavelength of three components was at 241 nm.Results The regression equation of levofloxacin hydrochloride,dexamethasone sodium phosphate and ethyl p-hydroxybenzoate was linear in the range from 8.56 to 137.20 μg/ml（r=0.9999,n=5）,from 1.25-20.00 μg/ml（r=0.9999,n=5）,and from 0.75-12.00 μg/ml（r=0.9999,n=5）,respectively.The mean sample recovery of three components was 100.92%,102.14%,101.29%,respectively.Good precision of three components was found below 1.00%.Conclusion The method is stable and accurate.It is a good method to control the quality of compound levofloxacin hydrochloride thermosensitive ophthalmic gels.