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目的采用HPLC法测定萘敏维滴眼液中的有关物质。方法采用Hibar RP-C_(18)色谱柱(250 mm×4.6 mm,5μm),梯度洗脱,流速1.0 m L·min~(-1),柱温30℃,检测波长223 nm,进样量50μL。结果在选定的色谱条件下,主成分与5种杂质的分离良好,线性范围为10~2×10~3ng·m L~(-1),最低检出限为0.04~0.85 ng。结论所用方法专属性强、准确度高,可用于检查萘敏维滴眼液中的有关物质。
Objective To determine the related substances in naphthalenemicarbazole eye drops by HPLC. Methods The gradient elution was carried out on a Hibar RP-C 18 column (250 mm × 4.6 mm, 5 μm) with a flow rate of 1.0 mL · min -1 and a detection wavelength of 223 nm at a detection wavelength of 223 nm. 50 μL. Results Under the selected chromatographic conditions, the separation of the main components from the five impurities was good, with a linear range of 10 ~ 2 × 10 ~ 3ng · m L -1 and a minimum detection limit of 0.04 ~ 0.85 ng. Conclusions The method used is highly specific and accurate, and can be used to examine the related substances in naphthalenemicarbazole eye drops.