Journal
JOURNAL OF CHROMATOGRAPHIC SCIENCE
Volume 52, Issue 10, Pages 1198-1203Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/chromsci/bmt177
Keywords
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Funding
- European Union
- European Regional Development Fund
- [TAMOP-4.2.1/B-09/1/KONV-2010-0005]
- [TAMOP-4.2.2/B-10/1-2010-0012]
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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.
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