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Evaluation of impurities level of perindopril tert-butylamine in tablets

Authorized Users Only
2007
Authors
Medenica, Mirjana
Ivanović, D.
Magković, M.
Jančić, Biljana
Malenović, Anđelija
Article (Published version)
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Abstract
Perindopril tert-butylamine is a new member of angiotensin-converting enzyme inhibitors group used in the treatment of hypertension and heart failure. In this paper, the evaluation of reversed-phase high-performance liquid chromatographic method (RP-HPLC) for the determination of impurities level of perindopril tert-butylamine in tablets was done. The chromatograms were recorded using a Hewlett Packard 1100 chromatographic system with DAD detector. Separations were performed on a YMC-Pack C8 column (250 mm x 4.6 mm; 5 mu m particle size) at 50 degrees C column temperature. Mobile phase was a mixture of acetonitrile-potassium phosphate buffer (0.05 M) (37:63, v/v) (pH 2.5). pH of the mobile phase was adjusted with ortophosphoric acid. Mixture of acetonitrile-water (40:60, v/v) was used as a solvent. Injection volume was 50 mu l, flow rate 1.7 ml min(-1) and UV-detection was performed at 215 nm. The developed method subjected to method validation and parameters in terms of selectivity, l...inearity, precision, accuracy, limit of detection, limit of quantitation and robustness were defined. The validated method is suitable for the simultaneous determination of perindopril tert-butylamine as well as its impurities in pharmaceuticals.

Keywords:
perindopril tert-butylamine / perindoprilat / impurities / high-performance liquid chromatography / validation
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2007, 44, 5, 1087-1094
Publisher:
  • Elsevier Science BV, Amsterdam
Projects:
  • Formulisanje i Karakterizacija separacionih sistema za modelovanje retencionog ponašanja lekovitih supstancija uz hemometrijsku evaluaciju (RS-142077)

DOI: 10.1016/j.jpba.2007.05.008

ISSN: 0731-7085

PubMed: 17590561

WoS: 000249469000009

Scopus: 2-s2.0-34547757006
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/968
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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