title: A fast ultra high pressure liquid chromatographic method for qualification and quantification of pharmaceutical combination preparations containing paracetamol, acetyl salicylic acid and/or antihistaminics.
abstract: A fully validated UHPLC method for the identification and quantification of pharmaceutical preparations, containing paracetamol and/or acetyl salicylic acid, combined with anti-histaminics (phenylephrine, pheniramine maleate, diphenhydramine, promethazine) and/or other additives as quinine sulphate, caffeine or codeine phosphate, was developed. The proposed method uses a Waters Acquity BEH C18 column (2 mm × 100 mm, 1.7 μm) with a gradient using an ammonium acetate buffer pH 4.0 as aqueous phase and methanol as organic modifier. The obtained method was fully validated based on its measurement uncertainty (accuracy profile) and robustness tests. Calibration lines for all components were linear within the studied ranges. The relative bias and the relative standard deviations for all components were respectively smaller than 1.5% and 2%, the β-expectation tolerance limits did not exceed the acceptance limits of 10% and the relative expanded uncertainties were smaller than 5% for all of the considered components. A UHPLC method was obtained for the identification and quantification of these kind of pharmaceutical preparations, which will significantly reduce analysis times and workload for the laboratories charged with the quality control of these preparations.
authors.affiliation: Department of Pharmaco-Bromatology, Section Medicinal Products, Scientific Institute of Public Health (IPH), J. Wytmansstraat 14, 1050 Brussels, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Deconinck
authors.forename: P Y
authors.initials: PY
authors.lastname: Sacré
authors.forename: S
authors.initials: S
authors.lastname: Baudewyns
authors.forename: P
authors.initials: P
authors.lastname: Courselle
authors.forename: J
authors.initials: J
authors.lastname: De Beer
mesh_terms: D000082:Acetaminophen / Q000032:analysis*; D018712:Analgesics, Non-Narcotic / Q000032:analysis*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000032:analysis*; D001241:Aspirin / Q000032:analysis*; D002021:Buffers; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D004338:Drug Combinations; D004339:Drug Compounding; D017408:Guidelines as Topic; D006633:Histamine Antagonists / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D011786:Quality Control; D015203:Reproducibility of Results; D012997:Solvents / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D013696:Temperature; D013997:Time Factors
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D002021:Buffers; D004338:Drug Combinations; D006633:Histamine Antagonists; D012997:Solvents; D000082:Acetaminophen; D001241:Aspirin