HPLC法同时测定复方金刚烷胺氨基比林片中氨基比林和马来酸氯苯那敏的含量及含量均匀度

目的:建立同时测定复方金刚烷胺氨基比林片中氨基比林和马来酸氯苯那敏含量的高效液相色谱(HPLC)法,并考察马来酸氯苯那敏的含量均匀度.方法:色谱柱采用XBridge C18柱(4.6 mm×250 mm,5μm),流动相为0.05 mol·L-1磷酸二氢钠-乙腈(80:20)(用磷酸调pH值至2.5),流速为1.0 m...

HPLC determination of content and content uniformity of aminopyrine and chlorphenamine maleate in Compound Amantadine Aminopyrine Tablets

Objective:To establish an HPLC method for simultaneous determination of aminopyrine and chlorphenamine maleate in compound amantadine aminopyrine tablets,and to investigate the content uniformity of chlorphenamine maleate.Methods:The test was performed in XBridge C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of 0.05 mol·L^-1 sodium dihydrogen phosphate solution-acetonitrile(80∶20)(adjusting pH to 2.5 with phosphoric acid).The flow rate was set as 1.0 mL·min^-1,and the detection wavelength was 262 nm.The column temperature was 40℃,and the injection volume was 20μL.Results:The resolution between aminopyrine and chlorphenamine maleate peaks of compound amantadine aminopyrine tablets met the requirements.The linearity of aminopyrine and chlorphenamine maleate fell into 36-96μg·mL^-1(r=0.9999),12-32μg·mL^-1(r=0.9998),respectively.The average spiked recoveries of aminopyrine and chlorphenamine maleate were 99.92%with RSDs as 0.89%(n=9),and 100.70%with RSDs as 0.84%(n=9),respetively.The three batches of samples were determined.The contents of aminopyrine were 104.4%,104.2%and 99.5%,respectively.The contents of chlorphenamine maleate were 98.8%,102.8%and 101.5%,respectively.Conclusion:The established method is simple,rapid and accurate.It is suitable for content and content uniformity determination of aminopyrine and chlorphenamine maleate in compound amantadine aminopyrine tablets,which is conductive to the quality control.