Objective：To establish a high performance liquid chromatography method for the determination of paracetamol,caffine and chlorphenamine maleate in Ganmaoling granules and compound Ganmaoling granules. Methods：HPLC experiment was performed on an Inertsil ODS-3 column（250 mm×4.6 mm,5 μm）．The mobile phase consisted of acetonitrile and phosphate buffer solution（dissolve 11.5 g of ammonium dihydrogen phosphate in 1 000 mL of water,add 1.0 mL of phosphoric acid）with gradient elution at a flow rate of 1.0 mL·min-1．The detection wavelength was set at 264 nm．Since the content of paracetamol was higher than that of caffeine and chlorpheniramine maleate in the formulation,the injection volumes were 5 μL and 100 μL,respectively. Results：The results showed that the separation of paracetamol,caffeine and chlorpheniramine maleate was good．The linear ranges of paracetamol, caffeine and chlorpheniramine maleate were 0.131 7-1.185,0.010 38-0.093 42 and 0.001 802~0.016 22 mg· mL-1,respectively,the corresponding linear correlation coefficients were all 0.999 9．The RSDs of stability and repeatability tests were less than 2.0%．The average recoveries of Ganmaoling granules were 100.6 %,100.0% and 100.1%（n=9）,and the average recoveries of compound Ganmaoling granules were 101.0 %,100.3% and 101.0%（n=9）,respectively．The contents（n=2）of paracetamol,caffine and chlorphenamine maleate in Ganmaoling granules were 104.2%-109.0%,96.0%-96.5% and 101.2%-105.5%,and the contents（n=2）of paracetamol,caffine and chlorphenamine maleate in compound Ganmaoling granules were 11.403,0.806 and 0.193 mg·g-1,respectively. Conclusion：The HPLC method is simple with high recovery,good precision and stability, and the method is applied successfully to determine paracetamol,caffeine and chlorpheniramine maleate in Ganmaoling granules and compound Ganmaoling granules．
GU Yi-ping, QIAO Ge, YANG Yuan
. HPLC determination of paracetamol,caffine and chlorphenamine maleate in Ganmaoling granules and compound Ganmaoling granules[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(2)
: 338
-344
.
DOI: 10.16155/j.0254-1793.2021.02.18
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