盐酸地芬尼多片溶出度考察

Study on the dissolution rate of difenidol hydrochloride tablets

目的 :对盐酸地芬尼多片进行溶出度测定 ,以考察其质量。方法 :采用高效液相色谱法测定了盐酸地芬尼多片的溶出度。色谱柱 :YWG- C1 8柱 ;流动相 :甲醇 - 0 .5 %三乙胺溶液 (磷酸调 p H值为 3.5 ) (6 2∶ 38) ;检测波长 ;2 15 nm。结果 :各 (厂 )批产品溶出参数 (T5 0 、Td、m) 有极显著差异 (P<0 .0 1)。结论

OBJECTIVE:To determine dissolution of various difenidol hydrochloride tablets and investigate its quality.METHOD:The dissolution of difenidol hydrochloride tablets was determined by HPLC.The mobile phase was methanol-0.5% triethylamine solution(62∶38).The detection wavelength was 215nm.The pH of 0.5% triethylamine solution was adjusted to 3.5 with phosphoric acid.RESULTS:The dissolution parameters(T 50 ,T d,m) of difenidol hydrochloride tablets from four pharmaceutical factories(seven batches) have very significant difference( P <0.01).CONCLUSION:Dissolution rate test is needed for controlling the quality of difenidol hydrochloride tablets.