HPLC法测定阿苯达唑片的含量与有关物质

Determination of Content and Related Substances of Albendazole Tablets by HPLC

目的:建立高效液相色谱法测定阿苯达唑片的含量与有关物质。方法:采用Agilent XDB-C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相:0.015 mo 1·L^(-1)磷酸二氢铵-甲醇(30:70),流速0.8 ml·min^(-1),检测波长295 nm,柱温30℃,进样量20μl。结果:阿苯达唑在6.25~125.00μg·ml^(-1)范围内线性关系良好(r=0.999 9),平均回收率为100.2%(RSD=0.6%,n=9),有关物质各杂质峰与阿苯达唑峰的分离度良好,检测限为2 ng。结论:本方法简便、快速、准确,专属性好,可用于阿苯达唑片含量和有关物质的测定。

Objective ： To establish an HPLC method for determination of the content and related substances of albendazole tablets. Methods： An Agilent XDB-C18 column（250 mm ×4.6 mm, 5 μm） was adopted for the HPLC analysis, the mobile phase was 0.015 mo 1 · L - l ammonium phosphate monobasic-methanol （ 30 ： 70 ） with a flow rate of 0.8 ml ·min - 1 , the detection wavelength was 295nm, the column temperature was at 30℃ and the injection volume was 20 μ1. Results： The linear range of albendazole was 6.25- 125.00 μg · ml-1 （ r = 0.9999 ）. The average recovery was 100.2% （ RSD = 0.6%, n = 9）. Albendazole and the related substance could be well separated. The detection limit was 2ng. Conclusion ： The method is simple, rapid and accurate, and suitable for the de- termination of albendazole tablets and the related substances.