Key result
Degradation products of Clopidogrel Bisulfate under hydrolytic and oxidative stress were identified as (S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl) acetic acid and others.
The study successfully identified the specific chemical degradation products of clopidogrel bisulfate under hydrolytic and oxidative stress conditions.
Alerts to clopidogrel formulation stability risks; extends analytical data but leaves clinical impact open.
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.
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Housheh et al. (2015) studied this question. Hydrolytic and oxidative stress conditions was evaluated on Identification and characterization of Clopidogrel Bisulfate degradation products. Degradation products of Clopidogrel Bisulfate under hydrolytic and oxidative stress were identified as (S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl) acetic acid and others.
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