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

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。

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, 5 μm） 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 1.02-16.32 μg·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.