Simultaneous determination of four sweeteners in Pediatric paracetamol,atificial cow-bezoar and chlorphenamine maleate preparations by HPLC
OBJECTIVE To determine sweeteners including potassium acesulfame,sodium saccharine,aspartame and stevioside in Pediatric paracetamol,atificial cow-bezoar and chlorphenamine maleate preparations by HPLC.METHODS The separation was conducted on an Agilent SB-C18(250 mm ×4.6 mm,5 μm)column coupled with the detection wavelength setting at 200 nm for sodium saccharine,aspartame and stevioside,226 nm for potassium acesulfame.The mobile phase consisted of 0.02 mol·L-1 ammonium dihydrogensolution(pH4.4)(A)and acetonitrile(B)with gradient elution with The flow rate of 1.0 mL·min-1.The column temperature was 30 ℃ and the injection volume was 10 μL.RESULTS Good separation of 4 sweeteners and other excipients were achieved.The linear ranges of potassium acesulfame,sodium saccharinem,aspartame and stevioside were 1.012-404.800 μg·mL-1(r=0.9999),1.117-223.400 μg·mL-1(r=0.9999),1.180-471.800 μg·mL-1(r=0.9997),and 0.605-605.200 μg·mL-1(r=0.9999),respectively.The quantitation limits of detection 19.7 ng·mL-1,8.0 ng·mL-1,11.2 ng·mL-1,and 25.4 ng·mL-1,respectively.The limits of detection were 65.7 ng·mL-1,26.0 ng·mL-1,37.5 ng·mL-1,and 84.7 μg·mL-1,respectively.The average recoveries were 97.81％,98.30％,98.00％and 101.10％,with the RSDs of 1.84％,1.39％,0.71％,and 1.98％(n=9),respectively.CONCLUSION The method shows high selectivity and sensitivity.The determination results can be applied for monitoring of the manufacturing process.
Pediatric paracetamol,atificial cow-bezoar and chlorphenamine maleateSweetenersPotassium acesulfameSodium saccharinemAspartameSteviosideOne test multi-evaluationHPLCContent determination
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