Determination of paracetamol and its main impurity 4-aminophenol in analgesic preparations by micellar electrokinetic chromatography.
A micellar electrokinetic chromatographic (MEKC) method was developed for the quality control of paracetamol containing pharmaceutical preparations. The influence of several factors (surfactant concentration, buffer concentration, pH and applied voltage) was studied during development and optimisation of the method. Phosphate buffer (pH 9.0) containing sodium dodecyl sulphate (75 mM) was found as the ideal running buffer for the separation; the applied voltage was 25 kV and the analysis time was 10 min. The limit of quantitation for 4-aminophenol was 6 microgml(-1); the linearity of the method was studied in the concentration ranges 20-260 microgml(-1) for paracetamol and 20-150 microgml(-1) for 4-aminophenol. The method was successfully applied for the quality control of paracetamol containing products.
Németh
Tamás
T
National Institute of Pharmacy, P.O. Box 450, H-1372 Budapest, Hungary. ntamas@ogyi.hu
Jankovics
Péter
P
Németh-Palotás
Júlia
J
Koszegi-Szalai
Hilda
H
D000082:Acetaminophen / Q000032:analysis*; D000627:Aminophenols / Q000032:analysis*; D018712:Analgesics, Non-Narcotic / Q000032:analysis*; D002021:Buffers; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D004563:Electrochemistry; D006863:Hydrogen-Ion Concentration; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry; D013501:Surface-Active Agents / Q000737:chemistry; D013997:Time Factors
D000627:Aminophenols; D018712:Analgesics, Non-Narcotic; D002021:Buffers; D004364:Pharmaceutical Preparations; D013501:Surface-Active Agents; D000082:Acetaminophen; D012967:Sodium Dodecyl Sulfate