HPLC测定N-三苯基甲基-5-(4'-溴甲基联苯-2-基)四氮唑中的有关物质

Determination of the related substances in N-triphenylmethyl-5-(4'-bromomethylbiphenyl-2-yl-) terazole by HPLC

目的采用HPLC法测定N-三苯基甲基-5-（4’-溴甲基联苯-2-基）四氮唑中的有关物质。方法采用Hypersil BDSC18色谱柱（150mm×4．6mm，5μm），流动相为乙腈-水（75：25），检测波长220nm，流速1．0mL·min^-1，柱温30℃。结果0．0199—498．4μg·mL^-1N-三苯基甲基-5-（4’-溴甲基联苯-2-基）四氮唑与峰面积的线性关系良好（r=0．9999），检测限为0．106ng，定量限为0．318ng。结论所用方法准确、灵敏、快速，适用于N-三苯基甲基-5-（4’-溴甲基联苯-2-基）四氮唑中有关物质的检查。

OBJECTIVE To establish an HPLC method to determine the related substances in N- triphenylmethyl -5 - （4＇- bromomethylbiphenyl - 2 - yl） terazole. METHODS Analysis was carried out on a Hypersil BDS Cls column （ 150 mm× 4.6 mm, 5 μm） using acetonitrile - water（75 ： 25 ） as mobile phase at detective wavelength of 220 nm. The flow rate was 1.0 mL. rain -1 and the temperature was 30 ℃. RESULTS The linear range of N - triphenylmethyl - 5 - （ 4＇ - bromomethylbiphenyl - 2 - yl ） terazole was 0. 0199 - 498.4 μg·mL^ - 1 （ r = 0. 9999 ）. The detection limits of N - triphenylmethyl - 5 - （4＇ - bromomethylbiphenyl - 2 - yl） terazole was 0. 106 ng. The limit of quantitation was 0. 318 ng. CONCLUSION The method is accurate, sensitive and rapid for quality control of the related substances in N - triphenylmethyl - 5 - （4＇ - bromomethylbiphenyl - 2 - yl） terazole.