HPLC测定萘敏维滴眼液中的有关物质

Determination of the related substances in Naphazoline hydrochloride,Chlorphenamine maleate and Vitamin B_(12) eye drops by HPLC

目的采用HPLC法测定萘敏维滴眼液中的有关物质。方法采用Hibar RP-C_(18)色谱柱(250 mm×4.6 mm,5μm),梯度洗脱,流速1.0 m L·min^(-1),柱温30℃,检测波长223 nm,进样量50μL。结果在选定的色谱条件下,主成分与5种杂质的分离良好,线性范围为10~2×10~3ng·m L^(-1),最低检出限为0.04~0.85 ng。结论所用方法专属性强、准确度高,可用于检查萘敏维滴眼液中的有关物质。

OBJECTIVE To establish an HPLC method to determine the related substances in Naphazoline hydrochloride,Chlorphenamine maleate and Vitamin B（12） eye drops（ NCVED）. METHODS A Hibar RP-C（18） column was used. Gradient elution was adopted and the detection wavelength was 223 nm with the flow rate of 1. 0 m L·min-1. Column temperature was 30 ℃ and the injection volume was 50 μL. RESULTS Principal component was completely separated from five impurities. The linear ranges were 10-2 × 103ng·m L^（-1）,and the LOQs were 0. 04-0. 85 ng. CONCLUSION The method is specific,accurate and suitable for analyzing the related substances in NCVED.