摘要
目的:建立双氯芬酸钠滴眼液有关物质高效液相色谱检查法。方法:以十八硅烷键合硅胶为填充剂;以0.03mol/L磷酸溶液-0.2%醋酸(V/V)甲醇溶液(33∶67)为流动相;流速:1.0m L/min;柱温:室温;检测波长:222nm;进样量:20μL。结果:该方法中有关物质之间及有关物质与主峰分离良好;检测限为0.1996ng;应在2h内完成测定。结论:该法操作简便、专属,能有效快速地控制产品质量。
Objective： To determine the content of related substances of Diclofeuac Sodium Eye Drops by HPLC. Methods： The chromatographic conditions were as follows： the column was C18 ; the mobile phase was 0.03mol/L phosphoric acid -0.2% acetic acid in methanol （33： 67） ; the flow rate was 1.0mL/min; the UV detection was at 222nm; the injection volume was 20μL. Results： Using the above methods, related substances, related material and main peak were separated very well; The detection limits were 0. 1996 ng for diclofenac sodium; The determination should be completed within 2 hours. Conclusion： The method is simple, selective, accurate and fast for quality Control.
出处
《江西中医药大学学报》
2014年第6期65-68,共4页
Journal of Jiangxi University of Chinese Medicine
