高效液相色谱法测定氨酚那敏三味浸膏胶囊对乙酰氨基酚溶出度的研究

Determination of the Dissolution of Paracetamol in Paracetamol and Chlorphenamine Maleate with Three Herb Extracts Capsules

目的:建立高效液相色谱(HPLC)法测定氨酚那敏三味浸膏胶囊中对乙酰氨基酚的溶出度的方法。方法:以0.1 mol.L-1盐酸水作为溶出介质,采用转篮法,转速为100 r.min-1,溶出时间60 min,HPLC法测定对乙酰氨基酚的溶出度。结果:对乙酰氨基酚在0.15～1.50μg范围内呈良好的线性关系(r=0.999 9);平均回收率100.2%(RSD-1.11%)。对乙酰氨基酚在60 min的溶出率为78.5%。结论:该方法简单易操作,重现性好,准确性高,结果稳定,可用于氨酚那敏三味浸膏胶囊中对乙酰氨基酚溶出度的测定。

Objective：To establish the method of the dissolubility of paracetamol in Paracetamol and Chlorphenamine Maleate with Three Herb Extracts Capsules by HPLC.Methods：The basket-stirring method was used with distilled water as dissolution medium at a rotate speed of 100 r·min-1,and the dissolving time was 60 minutes.The dissolution rate was determined by HPLC.Results：The lineatity of Paracetamol was in the ranges of 0.15-1.50 μg（RSD=0.999 9）.The average recoveries was 100.2%（RSD=1.11%）.The release rate of paracetamol at 60 min was 78.5%.Conclusion：The assay demonstrates that the method is simple,has adequate accuracy and selectivity to quantify the dissolution of paracetamol in Paracetamol and Chlorphenamine Maleate with Three Herb Extracts Capsules.