The present work describes forced degradation study of valdecoxib, under different ICH recommended stress conditions - photolytic degradation, oxidation, hydrolysis in alkaline and acidic conditions as well as its thermal degradation. Stress studies were performed at valdecoxib drug substance and the final dosage form. Chromatographic separations of drug and the degradation products formed under various experimental conditions was successfully achieved on RP-18e Chromolith® performance monolithic column (100 mm × 4.6 mm, macropore size 2 μm, mesopore size 13 nm) with an eluent containing the mixture of methanol and water solution of TEA (1%, pH 7.4) in the ratio 40:60 (v/v) while the column temperature was adjusted to 30°C. Detection was performed using photodiode array detector on several wavelengths in order to ensure the proper insight into drug degradation pathway in case the formed products differ in absorption characteristics.
TY - JOUR
AU - Pejović, Gordana
AU - Otašević, Biljana
AU - Zečević, Mira
AU - Kuntić, Vesna
AU - Vujić, Zorica
PY - 2010
UR - http://farfar.pharmacy.bg.ac.rs/handle/123456789/1432
AB - The present work describes forced degradation study of valdecoxib, under different ICH recommended stress conditions - photolytic degradation, oxidation, hydrolysis in alkaline and acidic conditions as well as its thermal degradation. Stress studies were performed at valdecoxib drug substance and the final dosage form. Chromatographic separations of drug and the degradation products formed under various experimental conditions was successfully achieved on RP-18e Chromolith® performance monolithic column (100 mm × 4.6 mm, macropore size 2 μm, mesopore size 13 nm) with an eluent containing the mixture of methanol and water solution of TEA (1%, pH 7.4) in the ratio 40:60 (v/v) while the column temperature was adjusted to 30°C. Detection was performed using photodiode array detector on several wavelengths in order to ensure the proper insight into drug degradation pathway in case the formed products differ in absorption characteristics.
T2 - Farmaceutyczny Przeglad Naukowy
T1 - Valdecoxib stability properties under forced degradation conditions
VL - 7
IS - 9
SP - 11
EP - 17
ER -
@article{
author = "Pejović, Gordana and Otašević, Biljana and Zečević, Mira and Kuntić, Vesna and Vujić, Zorica",
year = "2010",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/1432",
abstract = "The present work describes forced degradation study of valdecoxib, under different ICH recommended stress conditions - photolytic degradation, oxidation, hydrolysis in alkaline and acidic conditions as well as its thermal degradation. Stress studies were performed at valdecoxib drug substance and the final dosage form. Chromatographic separations of drug and the degradation products formed under various experimental conditions was successfully achieved on RP-18e Chromolith® performance monolithic column (100 mm × 4.6 mm, macropore size 2 μm, mesopore size 13 nm) with an eluent containing the mixture of methanol and water solution of TEA (1%, pH 7.4) in the ratio 40:60 (v/v) while the column temperature was adjusted to 30°C. Detection was performed using photodiode array detector on several wavelengths in order to ensure the proper insight into drug degradation pathway in case the formed products differ in absorption characteristics.",
journal = "Farmaceutyczny Przeglad Naukowy",
title = "Valdecoxib stability properties under forced degradation conditions",
volume = "7",
number = "9",
pages = "11-17"
}
Pejović, G., Otašević, B., Zečević, M., Kuntić, V.,& Vujić, Z. (2010). Valdecoxib stability properties under forced degradation conditions.
Farmaceutyczny Przeglad Naukowy, 7(9), 11-17.
Pejović G, Otašević B, Zečević M, Kuntić V, Vujić Z. Valdecoxib stability properties under forced degradation conditions. Farmaceutyczny Przeglad Naukowy. 2010;7(9):11-17
