高效液相色谱法测定盐酸非索非那定片中的有关物质A

Determination of the Related Substance A in Fexofenadine Hydrochloride Tablets by HPLC

目的建立高效液相色谱法测定盐酸非索非那定片中的有关物质A。方法采用Ultimate XB-C_(18)(250×4.6 mm,5μm)色谱柱,以乙腈-磷酸盐缓冲液〔取磷酸二氢钠(NaH_(2)PO_(4)·2H_(2)O)7.8 g,辛烷磺酸钠2.16 g,加水1000 mL使溶解,用磷酸调节pH值至3.0〕(40∶60)为流动相,流速为1.0 mL·min^(-1),进样量10μL,检测波长为220 nm。结果盐酸非索非那定有关物质A在(0.2655~5.310)μg·mL^(-1)范围内浓度与峰面积呈良好的线性关系(r=1.0000),有关物质A平均回收率为99.04%,RSD为0.24%(n=6)。结论本方法简便、快速,结果准确。

OBJECTIVE To establish an HPLC method for the determination of the related substance A in fexofenadine hydrochloride tablets.METHODS Ultimate XB-C_(18)(250×4.6 mm,5μm)column was used with acetonitrile-phosphate buffer solution[7.8 g sodium dihydrogen phosphate(NaH_(2)PO_(4)·2H_(2)O)and 2.16 g sodium octane sulfonate are dissolved with 1000 mL water.The mobile phase was adjusted to pH 3.0 with phosphoric acid](40∶60),the flow rate was 1.0 mL·min^(-1),the injection volume was 10μL and the detection wavelength was 220 nm.RESULTS The linear range of the related substance A of fexofenadine hydrochloride was 0.2655μg·mL^(-1) to 5.310μg·mL^(-1)(r=1.0000).The average recovery of the related substance A was 99.04% with RSD of 0.24%(n=6).CONCLUSION The method is simple,rapid and accurate.