酚氨咖敏片溶出度方法的建立及国内产品质量的考察

Establishment of the dissolution method and assessment of Fen′ankamin Tablets

目的建立酚氨咖敏片的溶出度检查方法并对国内产品进行质量现状考察。方法采用转篮法,100r·min-1,以900mL0.1mol·L-1盐酸为溶出介质,高效液相色谱法测定,检测波长272nm。结果经方法学验证,对乙酰氨基酚、咖啡因和氨基比林的检测质量浓度分别在0.034 9～0.244 0,0.006 2～0.043 7和0.022 5～0.157 4mg·L-1范围内线性关系良好(r>0.999 8),平均回收率均大于97.0%(RSD小于1.0%)。结论所建立的方法准确可靠,可作为酚氨咖敏片中各组分溶出度测定方法。

Objective To establish a method for determination of dissolution of Fen′ankamin Tablets,and to assess the dissolution of Fen′ankamin Tablets from domestic manufactures.Methods Rotating basket method was applied.The rotation speed was kept at 100 r·min^-1,and 900 mL 0.1 mol·L^-1 hydrochloric acid was used as the solvent.The analysis was carried out by HPLC,and the detection wavelength was at 272 nm.Results A good linearity（r0.999 8） of acetaminophen,caffeine and aminopyrine were showed in the ranges of 0.034 9-0.244 0,0.006 2-0.043 7,and 0.022 5-0.157 4 mg·L^-1,respectively.Conclusion The method is simple,accurate,reproducible and reliable,and it could be used for the determination of dissolution of Fen′ankamin Tablets.