Impurity profile analysis of drug products containing acetylsalicylic acid: a chemometric approach

• Authors: Joanna Ronowicz , Bogumiła Kupcewicz , Joanna Mydłowska , Elżbieta Budzisz
• Languages of publication: EN

Abstracts

EN

In this work attention is focused on impurity profile analysis in combination with infrared spectroscopy and chemometric methods. This approach is considered as an alternative to generally complex and time-consuming classic analytical techniques such as liquid chromatography. Various strategies for constructing descriptive models able to identify relations among drug impurity profiles hidden in multivariate chromatographic data sets are also presented and discussed. The hierarchical (cluster analysis) and non-hierarchical segmentation algorithms (k-means method) and principal component analysis are applied to gain an overview of the similarities and dissimilarities among impurity profiles of acetylsalicylic acid formulations. A tree regression algorithm based on infrared spectra is used to predict the relative content of impurities in the drug products investigated. Satisfactory predictive abilities of the models derived indicate the possibility of implementing them in the quality control of drug products. [...]

Keywords

EN

Acetylsalicylic acid; Descriptive models; Impurity profiling; Infrared spectroscopy; Predictive models

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2013
• Volume: 11
• Issue: 7
• Pages: 1091-1100

Dates

published

1 - 7 - 2013

online

26 - 4 - 2013

Contributors

author

Joanna Ronowicz

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

author

Bogumiła Kupcewicz

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

author

Joanna Mydłowska

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

author

Elżbieta Budzisz

• Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland

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Identifiers

DOI

10.2478/s11532-013-0243-2