Sibinović, Predrag

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  • Sibinović, Predrag (3)
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Author's Bibliography

Study of the Influence of Primary Packaging on Photostability of Tablets Containing Carvedilol

Savić, Ivan; Marinković, Valentina; Savić, Ivana; Sibinović, Predrag

(Assoc Pharmaceutical Teachers India, Bangalore, 2011)

TY  - JOUR
AU  - Savić, Ivan
AU  - Marinković, Valentina
AU  - Savić, Ivana
AU  - Sibinović, Predrag
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1498
AB  - The aim of this work was to select an appropriate primary packaging and analysis of its influence on stability, of tablets containing Carvedilol (Karvileks, Zdravlje-Actavis, Serbia). The influence of different primary packaging materials and doses radiation was investigated. Karvileks tablets were put in an opaque plastic container, red and white blister packs, composed of polyvinyl chloride and aluminum foil (PVC/Al). After radiation, the content was estimated using a validated HPLC method. Tablets, packaged in different primary packaging materials, were exposed at different doses of UV and VIS radiation. In case of blister packs, the content of active substance was lower than 85% compared with an initial content. Tablets packaged in the opaque plastic containers, the content of carvedilol was not lower than 90%, after radiation. The study showed that the opaque plastic containers provide better photo protection than red and white blister packs for solid oral dosage forms of Karvileks.
PB  - Assoc Pharmaceutical Teachers India, Bangalore
T2  - Indian Journal of Pharmaceutical Education and Research
T1  - Study of the Influence of Primary Packaging on Photostability of Tablets Containing Carvedilol
VL  - 45
IS  - 4
SP  - 353
EP  - 359
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1498
ER  - 
@article{
author = "Savić, Ivan and Marinković, Valentina and Savić, Ivana and Sibinović, Predrag",
year = "2011",
abstract = "The aim of this work was to select an appropriate primary packaging and analysis of its influence on stability, of tablets containing Carvedilol (Karvileks, Zdravlje-Actavis, Serbia). The influence of different primary packaging materials and doses radiation was investigated. Karvileks tablets were put in an opaque plastic container, red and white blister packs, composed of polyvinyl chloride and aluminum foil (PVC/Al). After radiation, the content was estimated using a validated HPLC method. Tablets, packaged in different primary packaging materials, were exposed at different doses of UV and VIS radiation. In case of blister packs, the content of active substance was lower than 85% compared with an initial content. Tablets packaged in the opaque plastic containers, the content of carvedilol was not lower than 90%, after radiation. The study showed that the opaque plastic containers provide better photo protection than red and white blister packs for solid oral dosage forms of Karvileks.",
publisher = "Assoc Pharmaceutical Teachers India, Bangalore",
journal = "Indian Journal of Pharmaceutical Education and Research",
title = "Study of the Influence of Primary Packaging on Photostability of Tablets Containing Carvedilol",
volume = "45",
number = "4",
pages = "353-359",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1498"
}
Savić, I., Marinković, V., Savić, I.,& Sibinović, P.. (2011). Study of the Influence of Primary Packaging on Photostability of Tablets Containing Carvedilol. in Indian Journal of Pharmaceutical Education and Research
Assoc Pharmaceutical Teachers India, Bangalore., 45(4), 353-359.
https://hdl.handle.net/21.15107/rcub_farfar_1498
Savić I, Marinković V, Savić I, Sibinović P. Study of the Influence of Primary Packaging on Photostability of Tablets Containing Carvedilol. in Indian Journal of Pharmaceutical Education and Research. 2011;45(4):353-359.
https://hdl.handle.net/21.15107/rcub_farfar_1498 .
Savić, Ivan, Marinković, Valentina, Savić, Ivana, Sibinović, Predrag, "Study of the Influence of Primary Packaging on Photostability of Tablets Containing Carvedilol" in Indian Journal of Pharmaceutical Education and Research, 45, no. 4 (2011):353-359,
https://hdl.handle.net/21.15107/rcub_farfar_1498 .

Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method

Stojanović, Jelena; Vladimirov, Sote; Marinković, Valentina; Veličković, Dragan; Sibinović, Predrag

(Srpsko hemijsko društvo, Beograd, 2007)

TY  - JOUR
AU  - Stojanović, Jelena
AU  - Vladimirov, Sote
AU  - Marinković, Valentina
AU  - Veličković, Dragan
AU  - Sibinović, Predrag
PY  - 2007
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/999
AB  - A sensitive, selective, precise and stability-indicating, new high-performance liquid chromatographic method for the analysis of carvedilol both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. The method was validated for linearity, selectivity, precision, robustness, LOD, LOQ and accuracy. The chromatographic separation was achieved on a Chromolit RP8e, 100x4.6 mm, analytical column. The mobile phase consisted of a mixture of acetonitrile and water (45:55, V/V) (pH 2.5), pH adjusted with formic acid. The absorbance was monitored with a UV detector at 280 nm and the temperature of the analyses was 40°C. The flow rate was 0.5 mL/min. The linearity (r≥ 0.999), reproducibility (0.68-1.27 %) and recovery (99.71-101.58) were found to be satisfactory. This method enables the simultaneous determination of carvedilol and its degradation products, as well as stability.
AB  - Karvedilol je neselektivni beta blokator sa vazodilatatornim i antioksidativnim svojstvima. Primenjuje se u terapiji hipertenzije, angine pektoris i kongestivne srčane insuficijencije. Razvijena je i validirana nova HPLC metoda za istovremenu kvalitativnu i kvantitativnu analizu karvedilola i njegovih nečistoća kao i za praćenje fotohemijske stabilnosti ovog jedinjenja. Metoda je validirana na linearnost, selektivnost, preciznost, robustnost, LOD, LOQ i tačnost. Optimalni uslovi postignuti su korišćenjem hromatografske kolone Chromolit RP 8e, 100x4,6 mm. Mobilnu fazu predstavlja smeša acetonitrila i vode u odnosu 45:55 pri pH 2,5. Analiza se odvija na temperaturi od 40°C pri protoku 0,5 ml/min a talasna dužina UV detektora iznosi 280 nm. Linearnost (r≥0,999), reproduktivnost (0,68-1,27%), i rikaveri (99,71-101,58) pokazuju zadovoljavajuće vrednosti. Hromatografska analiza je pokazala da se kao glavni proizvod degradacije karvedilola javlja 4-hidroksikarbazol, dok nečistoća C nije prisutna pod ovim uslovima. Predložena RP-HPLC metoda je brza, precizna, tačna, osetljiva, pouzdana i primenljiva za kvalitativnu i kvantitativnu analizu KarvileksR tablete, kao i za praćenje stabilnosti ovog leka.
PB  - Srpsko hemijsko društvo, Beograd
T2  - Journal of the Serbian Chemical Society
T1  - Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method
T1  - Praćenje fotohemijske stabilnosti karvedilola i njegovih degradacionih proizvoda RP-HPLC metodom
VL  - 72
IS  - 1
SP  - 37
EP  - 44
DO  - 10.2298/JSC0701037S
ER  - 
@article{
author = "Stojanović, Jelena and Vladimirov, Sote and Marinković, Valentina and Veličković, Dragan and Sibinović, Predrag",
year = "2007",
abstract = "A sensitive, selective, precise and stability-indicating, new high-performance liquid chromatographic method for the analysis of carvedilol both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. The method was validated for linearity, selectivity, precision, robustness, LOD, LOQ and accuracy. The chromatographic separation was achieved on a Chromolit RP8e, 100x4.6 mm, analytical column. The mobile phase consisted of a mixture of acetonitrile and water (45:55, V/V) (pH 2.5), pH adjusted with formic acid. The absorbance was monitored with a UV detector at 280 nm and the temperature of the analyses was 40°C. The flow rate was 0.5 mL/min. The linearity (r≥ 0.999), reproducibility (0.68-1.27 %) and recovery (99.71-101.58) were found to be satisfactory. This method enables the simultaneous determination of carvedilol and its degradation products, as well as stability., Karvedilol je neselektivni beta blokator sa vazodilatatornim i antioksidativnim svojstvima. Primenjuje se u terapiji hipertenzije, angine pektoris i kongestivne srčane insuficijencije. Razvijena je i validirana nova HPLC metoda za istovremenu kvalitativnu i kvantitativnu analizu karvedilola i njegovih nečistoća kao i za praćenje fotohemijske stabilnosti ovog jedinjenja. Metoda je validirana na linearnost, selektivnost, preciznost, robustnost, LOD, LOQ i tačnost. Optimalni uslovi postignuti su korišćenjem hromatografske kolone Chromolit RP 8e, 100x4,6 mm. Mobilnu fazu predstavlja smeša acetonitrila i vode u odnosu 45:55 pri pH 2,5. Analiza se odvija na temperaturi od 40°C pri protoku 0,5 ml/min a talasna dužina UV detektora iznosi 280 nm. Linearnost (r≥0,999), reproduktivnost (0,68-1,27%), i rikaveri (99,71-101,58) pokazuju zadovoljavajuće vrednosti. Hromatografska analiza je pokazala da se kao glavni proizvod degradacije karvedilola javlja 4-hidroksikarbazol, dok nečistoća C nije prisutna pod ovim uslovima. Predložena RP-HPLC metoda je brza, precizna, tačna, osetljiva, pouzdana i primenljiva za kvalitativnu i kvantitativnu analizu KarvileksR tablete, kao i za praćenje stabilnosti ovog leka.",
publisher = "Srpsko hemijsko društvo, Beograd",
journal = "Journal of the Serbian Chemical Society",
title = "Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method, Praćenje fotohemijske stabilnosti karvedilola i njegovih degradacionih proizvoda RP-HPLC metodom",
volume = "72",
number = "1",
pages = "37-44",
doi = "10.2298/JSC0701037S"
}
Stojanović, J., Vladimirov, S., Marinković, V., Veličković, D.,& Sibinović, P.. (2007). Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method. in Journal of the Serbian Chemical Society
Srpsko hemijsko društvo, Beograd., 72(1), 37-44.
https://doi.org/10.2298/JSC0701037S
Stojanović J, Vladimirov S, Marinković V, Veličković D, Sibinović P. Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method. in Journal of the Serbian Chemical Society. 2007;72(1):37-44.
doi:10.2298/JSC0701037S .
Stojanović, Jelena, Vladimirov, Sote, Marinković, Valentina, Veličković, Dragan, Sibinović, Predrag, "Monitoring of the photochemical stability of carvedilol and its degradation products by the RP-HPLC method" in Journal of the Serbian Chemical Society, 72, no. 1 (2007):37-44,
https://doi.org/10.2298/JSC0701037S . .
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Determination of carvedilol and its impurities in pharmaceuticals

Stojanović, J; Marinković, Valentina; Vladimirov, S; Veličković, D.; Sibinović, Predrag

(Vieweg, Wiesbaden, 2005)

TY  - JOUR
AU  - Stojanović, J
AU  - Marinković, Valentina
AU  - Vladimirov, S
AU  - Veličković, D.
AU  - Sibinović, Predrag
PY  - 2005
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/623
AB  - A reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for separation of carvedilol and its impurities from Karvileks tablets. The best separation was achieved on a 100 mm x 4.6 mm, 5 mu m particle size, Chromolit RP 8e column. Use of acetonitrile-water, 45:55 (v/v), adjusted to pH 2.5 with formic acid, as mobile phase at a flow rate of 0.5 mL min(-1) enabled acceptable resolution of carvedilol, in large excess, from possible impurities, in a short elution time. UV detection was performed at 280 nm. Linearity, accuracy, precision, selectivity, and robustness were validated and found to be satisfactory. Overall, the proposed method was found to be highly sensitive, suitable, and accurate for quantitative determination of carvedilol and its impurities in dosage forms and in raw materials.
PB  - Vieweg, Wiesbaden
T2  - Chromatographia
T1  - Determination of carvedilol and its impurities in pharmaceuticals
VL  - 62
IS  - 9-10
SP  - 539
EP  - 542
DO  - 10.1365/s10337-005-0656-y
ER  - 
@article{
author = "Stojanović, J and Marinković, Valentina and Vladimirov, S and Veličković, D. and Sibinović, Predrag",
year = "2005",
abstract = "A reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for separation of carvedilol and its impurities from Karvileks tablets. The best separation was achieved on a 100 mm x 4.6 mm, 5 mu m particle size, Chromolit RP 8e column. Use of acetonitrile-water, 45:55 (v/v), adjusted to pH 2.5 with formic acid, as mobile phase at a flow rate of 0.5 mL min(-1) enabled acceptable resolution of carvedilol, in large excess, from possible impurities, in a short elution time. UV detection was performed at 280 nm. Linearity, accuracy, precision, selectivity, and robustness were validated and found to be satisfactory. Overall, the proposed method was found to be highly sensitive, suitable, and accurate for quantitative determination of carvedilol and its impurities in dosage forms and in raw materials.",
publisher = "Vieweg, Wiesbaden",
journal = "Chromatographia",
title = "Determination of carvedilol and its impurities in pharmaceuticals",
volume = "62",
number = "9-10",
pages = "539-542",
doi = "10.1365/s10337-005-0656-y"
}
Stojanović, J., Marinković, V., Vladimirov, S., Veličković, D.,& Sibinović, P.. (2005). Determination of carvedilol and its impurities in pharmaceuticals. in Chromatographia
Vieweg, Wiesbaden., 62(9-10), 539-542.
https://doi.org/10.1365/s10337-005-0656-y
Stojanović J, Marinković V, Vladimirov S, Veličković D, Sibinović P. Determination of carvedilol and its impurities in pharmaceuticals. in Chromatographia. 2005;62(9-10):539-542.
doi:10.1365/s10337-005-0656-y .
Stojanović, J, Marinković, Valentina, Vladimirov, S, Veličković, D., Sibinović, Predrag, "Determination of carvedilol and its impurities in pharmaceuticals" in Chromatographia, 62, no. 9-10 (2005):539-542,
https://doi.org/10.1365/s10337-005-0656-y . .
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