Determination of Chlorphenamine Maleate and Its Related Substances in Compound Neostigmine Ophthalmic Gel by HPLC

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.