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，Eclipse XDB-C18色谱柱(4.6 mm×150 mm，5 μm)。流动相：甲醇-醋酸三乙胺溶液(45∶55)。检测波长：261 nm。结果线性范围为1.02～16.32 μg·mL-1，r=0.999 9。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，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.