摘要
目的 建立专属性强的HPLC法测定盐酸安非他酮缓释片含量。方法 采用Diamonsil^TM C18柱（200mm×4．6mm，5μm），以乙腈-0．1mol·L^-1磷酸二氢钾溶液-二乙胺（60：40：0．7）（用磷酸调节pH至7．5）作为流动相，检测波长为245nm，流速为1．0mL·min^-1。结果 本色谱条件能将盐酸安非他酮与其他降解产物有效分离；在26．5～265．0μg·mL^-1色谱峰面积与浓度呈良好的线性关系；平均回收率为99．94％，RSD为0．71％。结论 本法专属性强、准确、简便，可用于盐酸安非他酮缓释片的质量控制。
OBJECTIVE To establish an HPLC method to determinate amfebutamone hydrochloride in its sustained-release tablets. METHODS The DiamonsilTM C18 （200mm×4.6mm,5μm） column was used, and the mobile phase was composed of acetonitrile - 0.1 mol·L^-1 potassium dihydrogen phosphate solution - diethylamine （60 ： 40 ： 0. 7） （pH adjusted to 7.5 by H3PO4）, the detection wavelength was 245 nm, and the flow rate was 1.0 mL·min^-1. RESULTS The calibration curve was linear in 26. 5～265.0μg·mL^-1 , and r =0. 999 9. The average recovery was 99. 94% and RSD 0.71%. CONCLUSIONS This method is special, accurate and simple and can be used for the quality control of amfebutamone hydrochloride in its sustained-release tablets.
出处
《中南药学》
CAS
2006年第4期287-289,共3页
Central South Pharmacy
