HPLC法同时测定非索伪麻缓释双层片中盐酸非索非那定与盐酸伪麻黄碱的含量

Simultaneous determination of fexofenadine hydrochloride and pseudoephedrine hydrochloride in their sustained-release two-layer tablets by HPLC

目的测定非索伪麻缓释双层片中 2组分含量。方法采用氰基键合硅胶 (HypersilCN ,4 6mm× 2 0 0mm ,5 μm)为填充剂 ;流动相为乙腈 5mmol·L-1NH4H2 PO4(pH3 5 ,5 3∶4 7,V∶V )的高效液相色谱法 ;检测波长为 2 10nm ;柱温为 30℃ ;流速为 1 0mL·min-1。结果盐酸非索非那定与盐酸伪麻黄碱分别在质量浓度 2 0 2 8～ 10 1 4mg·L-1与 39 6 6～ 198 3mg·L-1内线性关系良好 ,相关系数r分别为 0 9999和 1。方法精密度RSD分别为 0 6 0 %和 0 35 % (n =6 ) ,平均回收率分别为 99 9%和 99 8% ,方法RSD分别为 0 5 1%和 0 38% (n =9)。

Objective To establish a HPLC method for simultaneously determining fexofenadine hydrochloride and pseudoephedrine hydrochloride in their sustained release two layer tablets.Method The chromatographic conditions included the Hypersil CN (4 6 mm× 200 mm , 5 μm ) column and the mobile phase consisting of a mixture of acetonitrile 5 mmol·L -1 NH 4H 2PO 4 solution(pH3 5,53∶47).The two components were detected at 210 nm .The flow rate was 1 0 mL·min -1 .Result The method has a good linearity and correlation coefficient: the fexofenadine hydrochloride is between 20 28～ 101 4 mg·L -1 and the pseudoephedrine hydrochloride is between 39 66～ 198 3 mg·L -1 .The recoveries are 99 9% and 99 8%,RSD are 0 51% and 0 38% respectively.Conclusion The method can well evaluate the quality of this preparation.