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HPLC测定复方新斯的明眼用凝胶中马来酸氯苯那敏的含量和有关物质
Determination of Chlorphenamine Maleate and Its Related Substances in Compound Neostigmine Ophthalmic Gel by HPLC
【摘要】 目的建立马来酸氯苯那敏及有关物质的含量测定方法。方法采用固相萃取-高效液相色谱法,EclipseXDB-C18色谱柱(4.6mm×150mm,5μm)。流动相:甲醇-醋酸三乙胺溶液(45∶55)。检测波长:261nm。结果线性范围为1.02~16.32μg·mL-1,r=0.9999。低、中、高3个浓度的平均回收率为(103.05±1.24)%,(100.87±1.45)%,(99.63±1.03)%。结论本方法简便快速、专属性好、重复性好、易操作。
【Abstract】 OBJECTIVE To establish an SPE-HPLC method for determining the content and related substances of chlorphenamine maleate.METHODS An eclipse XBD-C18 column(4.6 mm×150 mm,5μm)was used,and the mobile phase was methanol-acetate triethylamine solution(45︰55).The detective wavelength was 261 nm.RESULTS An excellent linearity(r=0.999 9) was obtained over the range of 1.02-16.32μg·mL- 1,the recovery of low,medium and high concentration level was(103.05±1.24)%, (100.87±1.45)%,(99.63±1.03)%.CONCLUSION This method is sensitive,specific,reproducible and easy to process.
【Key words】 chlorphenamine maleate; ophthalmic gel; related substances; SPE-HPLC;
- 【文献出处】 中国现代应用药学 ,Chinese Journal of Modern Applied Pharmacy , 编辑部邮箱 ,2009年06期
- 【分类号】R927
- 【被引频次】2
- 【下载频次】174