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

Czasopismo : Acta Chromatographica
Tytuł artykułu : Stress degradation studies on zolpidem tartrate using LC-DAD and LC-MS methods

Autorzy :
Komsta, Ł.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland, lukasz.komsta@am.lublin.pl,
Gowin, E.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland,
Djordjević Filijović, N.
Hemofarm AD Vrsac Serbia,
Pavlović, A.
Hemofarm AD Vrsac Serbia,
Nikolić, K.
University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia,
Agbaba, D.
University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia, danica@pharmacy.bg.ac.rs,
Sawant, S.
Sinhgad Technical Education Society’s Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk.) Pune 411 048 Maharashtra India, sawant99@rediffmail.com,
Barge, V.
PDEA’s Seth Govind Raghunath Sable College of Pharmacy Saswad, Tal-Purandar, Dist-Pune 412301 Maharashtra India,
Tiwari, R.
School of Pharmacy and Technology Department of Pharmaceutical Chemistry, SVKM’s NMIMS Management Shirpur Dist. Dhule 425405 Maharashtra India, ravisun4@rediffmail.com,
Bonde, C.
School of Pharmacy and Technology Department of Pharmaceutical Chemistry, SVKM’s NMIMS Management Shirpur Dist. Dhule 425405 Maharashtra India,
Bothara, K.
Sinhgad Institute of Pharmacy Department of Pharmaceutical Chemistry Narhe Road Pune 410041 Maharashtra India,
Nawaz, M.
United Arab Emirates University Department of Chemistry Al-Ain 17551 UAE, nawwaz@gmail.com,
Arayne, M. S.
University of Karachi Department of Chemistry Karachi 75270 Pakistan,
Sultana, N.
University of Karachi Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy Karachi 75270 Pakistan,
Haider, A.
University of Karachi Department of Chemistry Karachi 75270 Pakistan,
Hisaindee, S.
United Arab Emirates University Department of Chemistry Al-Ain 17551 UAE,
Youssef, R. M.
University of Alexandria Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry El-Messalah, Alexandria 21521 Egypt, rmmy1973@yahoo.com,
Malesevic, M.
Medicines and Medical Devices Agency of Serbia Vojvode Stepe 458 11 152 Belgrade Serbia,
Zivanovic, L.
University of Belgrade Faculty of Pharmacy, Department of Drug Analysis Vojvode Stepe 450 11 152 Belgrade Serbia, ljzivan@pharmacy.bg.ac.rs,
Protic, A.
University of Belgrade Faculty of Pharmacy, Department of Drug Analysis Vojvode Stepe 450 11 152 Belgrade Serbia,
Radisic, M.
University of Belgrade Faculty of Technology and Metallurgy, Department of Analytical Chemistry 11000 Belgrade Serbia,
Lausevic, M.
University of Belgrade Faculty of Technology and Metallurgy, Department of Analytical Chemistry 11000 Belgrade Serbia,
Jovic, Z.
Medicines and Medical Devices Agency of Serbia Vojvode Stepe 458 11 152 Belgrade Serbia,
Abstrakty : 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 : zolpidem tartrate, forced degradation, degradation products, column liquid chromatography, LC-MS,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2014
Numer : Vol. 26, no. 1
Strony : 81 – 96
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DOI :
Cytuj : Komsta, Ł. ,Gowin, E. ,Djordjević Filijović, N. ,Pavlović, A. ,Nikolić, K. ,Agbaba, D. ,Sawant, S. ,Barge, V. ,Tiwari, R. ,Bonde, C. ,Bothara, K. ,Nawaz, M. ,Arayne, M. S. ,Sultana, N. ,Haider, A. ,Hisaindee, S. ,Youssef, R. M. ,Malesevic, M. ,Zivanovic, L. ,Protic, A. ,Radisic, M. ,Lausevic, M. ,Jovic, Z. , Stress degradation studies on zolpidem tartrate using LC-DAD and LC-MS methods. Acta Chromatographica Vol. 26, no. 1/2014
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