Poly(ethyleneglycol) column for the determination of acetaminophen, phenylephrine and chlorpheniramine in pharmaceutical formulations.
New polar reversed-phase stationary phases in HPLC provide specific selectivities which can help to solve traditional chromatographic problems related to the development of chromatographic methods with widely different retention times for the sample components. One such case is the analysis of pharmaceutical formulations against the common cold. Acetaminophen, phenylephrine and chlorpheniramine, compounds with different polarities, are frequently associated in these drugs. An isocratic and rapid HPLC method for the simultaneous determination of the three compounds, acetaminophen, phenylephrine and chlorpheniramine, in capsules as pharmaceutical formulations, including the separation of impurities (4-aminophenol and 4-chloracetanilide) and excipients, has been developed and validated. The final chromatographic conditions employed a Supelco Discovery HS PEG column poly(ethyleneglycol) 15x0.46 cm, 5 microm. The mobile phase was 20 mM phosphate buffer, pH 7.0-acetonitrile (90:10, v/v) at a flow-rate of 1 ml/min. UV detection was performed at 215 nm for all the compounds except acetaminophen, which was measured at 310 nm. Validation parameters permit us to consider this method suitable.
García
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A
Facultad de CC Experimentales y de la Salud, Universidad S Pablo-CEU Urbanización Montepríncipe, Ctra Boadilla del Monte, km 5,3-28668 Madrid, Spain.
Rupérez
F J
FJ
Marín
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A
de la Maza
A
A
Barbas
C
C
D000082:Acetaminophen / Q000032:analysis*; D018712:Analgesics, Non-Narcotic / Q000032:analysis*; D002214:Capsules; D002744:Chlorpheniramine / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D006635:Histamine H2 Antagonists / Q000032:analysis*; D010656:Phenylephrine / Q000032:analysis*; D011092:Polyethylene Glycols / Q000737:chemistry*; D011786:Quality Control; D015203:Reproducibility of Results; D014662:Vasoconstrictor Agents / Q000032:analysis*
D018712:Analgesics, Non-Narcotic; D002214:Capsules; D006635:Histamine H2 Antagonists; D014662:Vasoconstrictor Agents; D010656:Phenylephrine; D000082:Acetaminophen; D002744:Chlorpheniramine; D011092:Polyethylene Glycols