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Journal
2013 | 11 | 8 | 1320-1329
Article title

Evaluation of impurities in simvastatin drug products with the use of FT-IR spectroscopy and selected chemometric techniques

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EN
Abstracts
EN
In the present study a reversed phase high performance liquid chromatography (RP-HPLC) method with diode array detector (DAD) at room temperature was used for obtaining impurity profiles of 20 drug products containing simvastatin as an active substance. Fourier-transform infrared spectroscopy (FT-IR) was carried out to obtain absorption spectra of samples. The partial least squares (PLS) model was built to predict the relative content of lovastatin, the main impurity of simvastatin, and sum of statin-like impurities. In order to build the PLS model, peak areas obtained from HPLC chromatograms were related to FT-IR spectra of drugs. The PLS model based on signal normal variate and orthogonal signal correction (SNV+OSC) transformed FT-IR spectra was able to predict the content of drug impurities in real samples with a good prediction ability (R2 > 0.95). [...]
Publisher

Journal
Year
Volume
11
Issue
8
Pages
1320-1329
Physical description
Dates
published
1 - 8 - 2013
online
1 - 6 - 2013
Contributors
  • Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland, kupcewicz@cm.umk.pl
  • Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland
  • Institute of Mathematics and Physics, University of Technology and Life Sciences, 85-796, Bydgoszcz, Poland
  • Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland
  • Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, 85-094, Bydgoszcz, Poland
References
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Document Type
Publication order reference
Identifiers
YADDA identifier
bwmeta1.element.-psjd-doi-10_2478_s11532-013-0264-x
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