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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 establish an HPLC method for the determination of fexofenadine hydrochloride and related substances in fexofenadine hydrochloride sustained-release tablets. Methods Hypersil CN column (4.6 mm × 200 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-0.005 mol·L-1 ammonium dihydrogen phosphate (volume ratio of 53:47, pH 3.5 with phosphoric acid) mL · min-1, the detection wavelength was 210 nm and the column temperature was 40 ℃. Results There was a good linear relationship between fexofenadine and 20-120 mg · L-1. The regression equation was 1.623 × 104ρ-5.830 × 103, r = 0.999 9, and the lowest detection limit was 3.0 mg · L-1. The method has good reproducibility and precision with RSD <2.0% and <2.5% respectively. The average recovery of the method was 99.5%, 99.8%, 99.8%, RSD 0.27%, 0.16%, 0.32% at low, medium and high concentrations of 80.0,120.0 and 140.0 g · L -1, respectively. Related substances can be well separated. Conclusion The method can be used for the quality control of fexofenadine hydrochloride sustained-release tablets.