阿苯达唑工作参照品的测定

Determination of working reference standard of Albendazole

目的建立测定阿苯达唑参照品含量的方法。方法用二极管阵列检测器优化检测条件,采用两种色谱条件,从对照品纯度与参照品归一两个方面测定。通过C18色谱柱反相分离,流动相分别用乙腈-水(磷酸调pH4.5)(55:45)和甲醇-水(磷酸调pH4.5)(65:35)测定阿苯达唑及相关物质的含量。结果阿苯达唑含量为99.8%。结论所建测定方法灵敏,能互相印证,结果准确可靠,可作为阿苯达唑工作参照品含量控制的定量方法。

OBJECTIVE To determine the content of the working reference standard of Albendazole. METHODS An HPLC method was adopted. DAD was used to improve the condition of determination and Albendazole standard was determined with two HPLC systems through two aspects above the purity and normalization of standard. Both methods used C18 column to separate Albendazole and the related substances by RP - HPLC ,but one used mobile phase consisted of acetonitrile - water with adjusting pH to 4.5 with phosphoric acid （ 55 ： 45 ） ,while the other one used methanol - water with adjusting pH to 4. 5 with phosphoric acid （ 65 ： 35 ）. RESULTS The content of Albendazole determined was 99.8%. CONCLUSION The method is sensitive, accurate and reliable. It can be used as a quantitative method in quality control of reference standard of Albendazole.