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Published on:9th Feb, 2015
Indian Journal of Pharmaceutical Education and Research, 2015; 49(4s):s1-s11
Pharmaceutical Research | doi:10.5530/ijper.49.4s.1

GC/MS, FTIR and NMR Studies for the Identification and Characterization of Clopidogrel Bisulfate Degradation Products


Authors and affiliation (s):

Samer Housheh1*, Saleh Trefi1, Mohammed Haroun2 and Mustafa Fawaz Chehna1

1Department of Quality Control and Pharmaceutical Chemistry, Faculty of Pharmacy, University of Aleppo, Syrian Arab Republic.

2Department of Quality Control and Pharmaceutical Chemistry, Faculty of Pharmacy, University of Tishreen, Syrian Arab Republic.

Abstract:

Clopidogrel Bisulfate is a thienopyridine derivative. The separation, identification and degradation of Clopidogrel Bisulfate under hydrolytic and oxidative stress conditions according to the International Conference on Harmonization (ICH) guideline Q1A (R2) was performed. TLC using (n-hexan:tetrahydrofuran)(1:1 v/v) as a mobile phase was used to separate the degradation products. Three compounds were isolated then analyzed using RP-HPLC which showed a purity of 99%. Mass fragmentation pathway of the compounds were first established with the help of GC/MS studies. Then, the degradation products were subjected to FTIR and 1H NMR studies. The obtained data were employed to characterize the degradation products and assign structures. The degradation products were identified as (S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl) acetic acid in acidic and basic media, 2-(2-chlorophenyl)-2-oxoacetic acid and 4,5,6,7-tetrahydrothieno [3,2-c] pyridine in oxidative medium.

Key words: Clopidogrel degradation products, FTIR, GC/MS, NMR, Stress studies.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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