RP-HPLC测定富马酸福莫特罗口腔崩解片

Determination of Formoterol Fumarate in Orally Disintegrating Tablets by RP-HPLC

建立RP-HPLC测定富马酸福莫特罗口腔崩解片的含量。采用ZORBAX SB-C18(150mm×4.6mm,5.0μm)色谱柱,以乙腈-30mmol/L NaH_2PO_4·H_2O(pH 3.1)-三乙胺(16:84:0.15,V/V/V)为流动相,流速为1.0mL/min,检测波长为214nm。富马酸福莫特罗在0.5—3.0μg/mL浓度范围内,峰面积与浓度呈良好线性(r=0.9995),加标回收率为98.8%—100.2%,RSD为0.68%—0.99%(n=4)。该方法简便、准确,可用于富马酸福莫特罗口腔崩解片的质量控制。

The determination of content of formoterol fumarate in orally disintegrating tablets by RP-HPLC was established.The compound was separated by a ZORBAX SB-C18 column （250mm×4.6mm,5.0μm） with mobile phase of acetonitrile-30mmol/L NaH2PO4 · H2O（pH 3.1）- triethylamine（16：84：0.15,V/V/V） at a flow rate of 1.OmL/min.Detection wavelength was 214nm.There was a good linearity in the range of 0.5-3.0μg/mL（r=0.9995）.The recoveries were from 98.8%to 100.2%with RSD（n = 4）of 0.68%-0.99%.The method is rapid,accurate and reliable,can be applied to quality control of formoterol fumarate in orally disintegrating tablets