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2013 | 11 | 8 | 1320-1329
Tytuł artykułu

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

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Warianty tytułu
Języki publikacji
EN
Abstrakty
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). [...]
Wydawca

Czasopismo
Rocznik
Tom
11
Numer
8
Strony
1320-1329
Opis fizyczny
Daty
wydano
2013-08-01
online
2013-06-01
Twórcy
  • 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
Bibliografia
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Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.-psjd-doi-10_2478_s11532-013-0264-x
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