HPLC法测定左旋氟比洛芬中的有关物质

Determination of the Related Substances of Flurizan by HPLC

应用高效液相色谱法测定左旋氟比洛芬中的有关物质。使用Kromasil C18色谱柱;流动相为2mmol.L-1十二烷基硫酸钠-乙腈-冰醋酸(55∶45∶0.1),流速为1.0 mL.min-1,检测波长为254nm。左旋氟比洛芬与各杂质分离良好,氟比洛芬杂质A、拆分剂L-酯和左旋氟比洛芬的最小检测限分别为0.002 ng、0.04 ng和0.004 ng。本法简便,灵敏度高,准确可靠。

A HPLC method for determination of the flurizan＇s related substances was established. The HPLC system was consisted of Kromasil C18 column, 2 mmol·L^-1 SDS-acetonitrile-acetic acid （55 ： 45 ： 0.1） as mobile phase at a flow rate of 1.0 mL·L^-1, the detection avelength was 254 nm. Good resolution for flurizan and related substances was obtained. The detection limits for impurity A of flurizan, L-ester as resolution reagent and flurizan were 0. 002 ng, 0.04 ng and 0. 004 ng respectively. The method is simple, sensitive and accurate.