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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 a method for the determination of fexofenadine hydrochloride in sustained release pellets of fexofenadine hydrochloride by high performance liquid chromatography. Methods: Kromasil C_ (18_ (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of acetonitrile-0.5% potassium dihydrogen phosphate solution (adjusted to pH 4.0 with phosphoric acid) nm, the flow rate was 1.0 ml · min -1, the column temperature was 35 ℃, and the injection volume was 20 μl.RESULTS: There was a linear relationship between fexofenadine hydrochloride and 30.23 ~ 302.30 μg · ml ~ (-1) (R = 0.999 7), the average recovery was 99.75%, RSD = 0.1% (n = 6) .Conclusion: The method is simple, accurate and specific and can be used for the determination of the content of this preparation.