Evaluation of impurities level of perindopril tert-butylamine in tablets
Само за регистроване кориснике
2007
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
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.
Кључне речи:
perindopril tert-butylamine / perindoprilat / impurities / high-performance liquid chromatography / validationИзвор:
Journal of Pharmaceutical and Biomedical Analysis, 2007, 44, 5, 1087-1094Издавач:
- Elsevier Science BV, Amsterdam
Финансирање / пројекти:
- Формулисање и Карактеризација сепарационих система за моделовање ретенционог понашања лековитих супстанција уз хемометријску евалуацију (RS-MESTD-MPN2006-2010-142077)
DOI: 10.1016/j.jpba.2007.05.008
ISSN: 0731-7085
PubMed: 17590561
WoS: 000249469000009
Scopus: 2-s2.0-34547757006
Институција/група
PharmacyTY - JOUR AU - Medenica, Mirjana AU - Ivanović, D. AU - Magković, M. AU - Jančić, Biljana AU - Malenović, Anđelija PY - 2007 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/968 AB - 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, linearity, 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. PB - Elsevier Science BV, Amsterdam T2 - Journal of Pharmaceutical and Biomedical Analysis T1 - Evaluation of impurities level of perindopril tert-butylamine in tablets VL - 44 IS - 5 SP - 1087 EP - 1094 DO - 10.1016/j.jpba.2007.05.008 ER -
@article{ author = "Medenica, Mirjana and Ivanović, D. and Magković, M. and Jančić, Biljana and Malenović, Anđelija", year = "2007", 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, linearity, 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.", publisher = "Elsevier Science BV, Amsterdam", journal = "Journal of Pharmaceutical and Biomedical Analysis", title = "Evaluation of impurities level of perindopril tert-butylamine in tablets", volume = "44", number = "5", pages = "1087-1094", doi = "10.1016/j.jpba.2007.05.008" }
Medenica, M., Ivanović, D., Magković, M., Jančić, B.,& Malenović, A.. (2007). Evaluation of impurities level of perindopril tert-butylamine in tablets. in Journal of Pharmaceutical and Biomedical Analysis Elsevier Science BV, Amsterdam., 44(5), 1087-1094. https://doi.org/10.1016/j.jpba.2007.05.008
Medenica M, Ivanović D, Magković M, Jančić B, Malenović A. Evaluation of impurities level of perindopril tert-butylamine in tablets. in Journal of Pharmaceutical and Biomedical Analysis. 2007;44(5):1087-1094. doi:10.1016/j.jpba.2007.05.008 .
Medenica, Mirjana, Ivanović, D., Magković, M., Jančić, Biljana, Malenović, Anđelija, "Evaluation of impurities level of perindopril tert-butylamine in tablets" in Journal of Pharmaceutical and Biomedical Analysis, 44, no. 5 (2007):1087-1094, https://doi.org/10.1016/j.jpba.2007.05.008 . .