HPLC法测定盐酸非索非那定缓释微丸胶囊的含量

Determination of Fexofenadine Hydrochloride Sustained Release Pellets Capsules by HPLC

目的:建立以高效液相色谱法测定盐酸非索非那定缓释微丸胶囊中盐酸非索非那定含量的方法。方法:以Kromasil C_(18_(250 mm×4.6 mm,5μm)为色谱柱,流动相为乙腈-0.5%磷酸二氢钾溶液(以磷酸调节pH至4.0)(55:45),检测波长为210 nm,流速为1.0 ml·min^(-1),柱温为35℃,进样量为20μl。结果:盐酸非索非那定在30.23~302.30μg·ml^(-1)范围内线性关系良好(r=0.999 7),平均回收率为99.75%,RSD=0.1%(n=6)。结论:本方法简便、准确、专属性强,可用于该制剂的含量测定。

Objective： To establish an HPLC method for the determination of fexofenadine hydrochloride sustained release pellets capsules. Method： An HPLC method was performed on a Kromasil Cjs （250 mm x 4.6 mm,5 ） column using acetonitrile -0.5% potassium dihydrogen phosphate solution （55： 45, adjusting pH to 4.0 with phosphate） as the mobile phase at a flow rate of 1.0 ml ~ min-I. The detection wavelength was at 210 nm. The column temperature was 35% and the sample volume was 20 . Result： The linear range of fexofenadine hydrochloride was 30.23-302.30 ~g ~ ml - 1 （ r = 0. 999 7 ）, and the average recovery was 99.75% （ RSD = 0.1%, n = 6）. Conclusion： The method is simple, accurate and specific, and can be used in the determination of fexofenadine hydro- chloride sustained release pellets capsules.