Simultaneous Determination of 4 Components in Compound Paracetamol and Amantadine Hydrochloride Tablet by GC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the simultaneous determination of paracetamol,amantadine hydrochloride, caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet. METHODS:GC was performed on the column of HP-5 sillica capillary,temperature programmed,detector was FID detector,with the temperature of 300 ℃,car-rier gas was nitrogen gas,the flow rate is 1.5 mL/min,the split ratio was 201 and injection volume was 1μL. RESULTS:The lin-ear range was 156.0-4990.4 μg/mL for paracetamol,125.7-4023.2 μg/mL for amantadine hydrochloride,19.14-612.4 μg/mL for caffeine and 2.515-80.48 μg/mL for chlorphenamine maleate(all r=0.9999);the limits of quantification were 1.4,0.5,1.1,0.9 ng,limits of detection were 0.4,0.2,0.3,0.3 ng;RSDs of precision,stability and reproducibility tests were lower than 2.0%;re-coveries were 99.59%-101.77%(RSD=0.8%,n=9),99.56%-101.80%(RSD=0.7%,n=9),98.44%-100.83%(RSD=0.7%,n=9) and 100.05%-101.91%(RSD=0.6%,n=9),respectively. CONCLUSIONS:This method is simple,rapid,accurate and reli-able,and suitable for the simultaneous determination of paracetamol,amantadine hydrochloride,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet.