HPLC法测定盐酸非索非那定缓释片中盐酸非索非那定及有关物质含量

Development and validation of an HPLC method for the determination of fexofenadine hydrochloride and its related substances in sustained release tablets

目的建立HPLC法测定盐酸非索非那定缓释片中盐酸非索非那定及有关物质的含量。方法采用Hypersil CN色谱柱(4.6 mm×200 mm,5μm);以乙腈–0.005mol·L-1磷酸二氢铵(体积比为53:47,用磷酸调节pH为3.5)为流动相,流速1.0 mL·min-1,检测波长210 nm,柱温为40℃。结果盐酸非索非那定在20~120 mg·L-1内线性关系良好,回归方程A=1.623×104ρ–5.830×103,r=0.999 9,最低检测限为3.0 mg·L-1。本方法的重现性和精密度良好,日内日间的RSD分别【2.0%、【2.5%。80.0、120.0、140.0 g·L-1低、中、高3种质量浓度下,方法的平均回收率分别为99.5%、99.8%、99.8%,RSD为0.27%、0.16%、0.32%。有关物质可很好分离。结论方法可用于盐酸非索非那定缓释片的质量控制。

Objective To develop an HPLC method for the determination of fexofenadine hydrochloride and its related substances in sustained release tablets. Method Fexofenadine hydrochloride and its related substances were separated using a mobile phase consisting of acetonitrile-buffer(0.005 mol·L-1monobasic ammonium phosphate, adjust pH to 3.5 by phosphoric acid)(V:V = 53:47) at a flow rate of 1.0mL·min-1on a Hypersil CN column(4.6 mm×200 mm, 5 μm) and detected at UV wavelength 210 nm. Result There was a good linear relationship within the range of 20–120 mg·L-1(r=0.999 9), The limit of detection(LOD)for the method was 3.0 μg·mL-1(S/N=3). The reproducibility and precision of the method are good. The intra-day RSD and inter-day RSD were less than 2.5% and 2.0%, respectively. The average method recoveries were 99.5%, 99.8% and 99.8% for the low(80.0 mg·L-1), middle(120.0 mg·L-1) and high(140.0 mg·L-1)concentrations of check samples, respectively. The related substance can be separated as wel1. Conclusion The method is simple, rapid, accurate and is suitable for the determination of content and related subsances of fexofenadine hydrochloride in sustained release tablets.