title: Simultaneous quantification of paracetamol, acetylsalicylic acid and papaverine with a validated HPLC method.
abstract: Combined drug products have the advantages of better patient compliance and possible synergic effects. The simultaneous application of several active ingredients at a time is therefore frequently chosen. However, the quantitative analysis of such medicines can be challenging. The aim of this study is to provide a validated method for the investigation of a multidose packed oral powder that contained acetylsalicylic acid, paracetamol and papaverine-HCl. Reversed-phase high-pressure liquid chromatography was used. The Agilent Zorbax SB-C18 column was found to be the most suitable of the three different stationary phases tested for the separation of the components of this sample. The key parameters in the method development (apart from the nature of the column) were the pH of the aqueous phase (set to 3.4) and the ratio of the organic (acetonitrile) and the aqueous (25 mM phosphate buffer) phases, which was varied from 7:93 (v/v) to 25:75 (v/v) in a linear gradient, preceded by an initial hold. The method was validated: linearity, precision (repeatability and intermediate precision), accuracy, specificity and robustness were all tested, and the results met the ICH guidelines.
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Somogyi u. 4, Szeged H-6720, Hungary.
authors.forename: Eva
authors.initials: E
authors.lastname: Kalmár
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Somogyi u. 4, Szeged H-6720, Hungary.
authors.forename: Anett
authors.initials: A
authors.lastname: Gyuricza
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Somogyi u. 4, Szeged H-6720, Hungary.
authors.forename: Erika
authors.initials: E
authors.lastname: Kunos-Tóth
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Somogyi u. 4, Szeged H-6720, Hungary gerda.szakonyi@pharm.u-szeged.hu.
authors.forename: Gerda
authors.initials: G
authors.lastname: Szakonyi
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Somogyi u. 4, Szeged H-6720, Hungary.
authors.forename: György
authors.initials: G
authors.lastname: Dombi
mesh_terms: D000082:Acetaminophen / Q000032:analysis*; D001241:Aspirin / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D010208:Papaverine / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000082:Acetaminophen; D010208:Papaverine; D001241:Aspirin