复方氨酚那敏颗粒中对乙酰氨基酚的溶出度测定

Dissolution determination of acetaminophen from compound paracetamol and chlorphenamine maleate granules

目的 建立复方氨酚那敏颗粒中对乙酰氨基酚的溶出度测定方法.方法 采用桨法,以900 ml水作为溶出介质,转速为50 r/min,以高效液相色谱法测定.采用C18柱,以磷酸二氢铵溶液（取磷酸二氢铵11.5 9,加水适量使溶解,加入磷酸1ml,加水稀释到1000 ml）-乙腈-甲醇（80∶10∶10）为流动相,检测波长为275 nm.结果 对乙酰氨基酚在0.0625～0.6250 mg/ml的范围内呈现良好的线性关系（r=0.9999）,平均回收率为100.4％,RSD值为0.44％（n=9）,样品溶出均一性好,在10 min时9个组分溶出度均达90％.结论 本方法快速、简便、结果准确,可作为该制剂的溶出度测定方法.

Objective To establish an dissolution determination method of acetaminophen from compound paracetamol and chlorphenamine maleate granules. Methods The paddle method was used and with 900 ml water as dissolution medium at the rotation speed of 50 r/min,the acetaminophen was determined by I-IPLC.The Cls column was used with the mobile phase of the two solution of ammonium phosphate[took two ammonium hydrogen phosphate（11.5 g） into the amount of water so that dissolved,then added phosphoric acid （1 ml）,Diluted to 1000 ml with water]-acetonitrile- methanol （80：10：10） at the detection wavelength of 278 nm. Results The linear range of acetaminophen was 0.0625-0.625 mg/ml（r =0.9999）,the average recovey（n=9） was 100.4%（RSD=0.44%）,The sample was dissolved out good unifor- mity,and in the l0 min the 9 component solubility reached 90%. Conclusion The methods is rapid,simple and accu- rate for assaying of dissolution of compound paracetamol and chlorphenamine maleate granules