TY  - JOUR
AU  - Malesević, M.
AU  - Živanović, Ljiljana
AU  - Protić, Ana
AU  - Radisić, Marina
AU  - Lausević, M.
AU  - Jović, Žarko
AU  - Zečević, Mira
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2150
AB  - The present study was designed to characterize the possible degradation products of zolpidem tartrate under various stress conditions according to International Conference on Harmonization (ICH) guidelines Q1A(R2). After exposure to light, heat, hydrolysis, and oxidation, the drug significantly degraded under photolytic and acid/base hydrolytic conditions. Degradation resulted in the formation of four key degradants. Degradation products were resolved from each other and the drug by employing an isocratic elution method on Luna C-18 column with mobile phase consisting of methanol-10 mM ammonium acetate (68.4: 31.6, v/v), wherein pH was adjusted to 5.4 with glacial acetic acid. To characterize the degradation products, a method was extended to LC-MS and a mass fragmentation pattern was established using single quad-rupole. The degradants were identified as zolpacid, oxozolpidem, zolpaldehyde, and zolpyridine. Finally, the most possible degradation mechanism of zolpidem tartrate in different environments was proposed.
PB  - Akademiai Kiado Zrt, Budapest
T2  - Acta Chromatographica
T1  - Stress Degradation Studies on Zolpidem Tartrate Using LC-DAD and LC-MS Methods
VL  - 26
IS  - 1
SP  - 81
EP  - 96
DO  - 10.1556/AChrom.26.2014.1.8
ER  - 

@article{
author = "Malesević, M. and Živanović, Ljiljana and Protić, Ana and Radisić, Marina and Lausević, M. and Jović, Žarko and Zečević, Mira",
year = "2014",
abstract = "The present study was designed to characterize the possible degradation products of zolpidem tartrate under various stress conditions according to International Conference on Harmonization (ICH) guidelines Q1A(R2). After exposure to light, heat, hydrolysis, and oxidation, the drug significantly degraded under photolytic and acid/base hydrolytic conditions. Degradation resulted in the formation of four key degradants. Degradation products were resolved from each other and the drug by employing an isocratic elution method on Luna C-18 column with mobile phase consisting of methanol-10 mM ammonium acetate (68.4: 31.6, v/v), wherein pH was adjusted to 5.4 with glacial acetic acid. To characterize the degradation products, a method was extended to LC-MS and a mass fragmentation pattern was established using single quad-rupole. The degradants were identified as zolpacid, oxozolpidem, zolpaldehyde, and zolpyridine. Finally, the most possible degradation mechanism of zolpidem tartrate in different environments was proposed.",
publisher = "Akademiai Kiado Zrt, Budapest",
journal = "Acta Chromatographica",
title = "Stress Degradation Studies on Zolpidem Tartrate Using LC-DAD and LC-MS Methods",
volume = "26",
number = "1",
pages = "81-96",
doi = "10.1556/AChrom.26.2014.1.8"
}

Malesević, M., Živanović, L., Protić, A., Radisić, M., Lausević, M., Jović, Ž.,& Zečević, M.. (2014). Stress Degradation Studies on Zolpidem Tartrate Using LC-DAD and LC-MS Methods. in Acta Chromatographica
Akademiai Kiado Zrt, Budapest., 26(1), 81-96.
https://doi.org/10.1556/AChrom.26.2014.1.8

Malesević M, Živanović L, Protić A, Radisić M, Lausević M, Jović Ž, Zečević M. Stress Degradation Studies on Zolpidem Tartrate Using LC-DAD and LC-MS Methods. in Acta Chromatographica. 2014;26(1):81-96.
doi:10.1556/AChrom.26.2014.1.8 .

Malesević, M., Živanović, Ljiljana, Protić, Ana, Radisić, Marina, Lausević, M., Jović, Žarko, Zečević, Mira, "Stress Degradation Studies on Zolpidem Tartrate Using LC-DAD and LC-MS Methods" in Acta Chromatographica, 26, no. 1 (2014):81-96,
https://doi.org/10.1556/AChrom.26.2014.1.8 . .