Stress degradation studies on zolpidem tartrate using LC-DAD and LC-MS methods

• Autorzy: Malesevic M. , Zivanovic L. , Protic A. , Radisic M. , Lausevic M. , Jovic Z. , Zecevic M.
• Języki publikacji: EN

Abstrakty

EN

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 C18 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 quadrupole. The degradants were identified as zolpacid, oxozolpidem, zolpaldehyde, and zolpyridine. Finally, the most possible degradation mechanism of zolpidem tartrate in different environments was proposed.

Słowa kluczowe

EN

zolpidem tartrate; forced degradation; degradation products; column liquid chromatography; LC-MS

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2014
• Tom: Vol. 26, no. 1
• Strony: 81--96
• Opis fizyczny: Bibliogr. 32 poz., rys., tab.

Twórcy

autor

Malesevic M.

• Medicines and Medical Devices Agency of Serbia Vojvode Stepe 458 11 152 Belgrade Serbia

autor

Zivanovic L.

• University of Belgrade Faculty of Pharmacy, Department of Drug Analysis Vojvode Stepe 450 11 152 Belgrade Serbia

autor

Protic A.

• University of Belgrade Faculty of Pharmacy, Department of Drug Analysis Vojvode Stepe 450 11 152 Belgrade Serbia

autor

Radisic M.

• University of Belgrade Faculty of Technology and Metallurgy, Department of Analytical Chemistry 11000 Belgrade Serbia

autor

Lausevic M.

• University of Belgrade Faculty of Technology and Metallurgy, Department of Analytical Chemistry 11000 Belgrade Serbia

autor

Jovic Z.

• Medicines and Medical Devices Agency of Serbia Vojvode Stepe 458 11 152 Belgrade Serbia

autor

Zecevic M.

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