Physico-chemical Studies on Stability of Clopidogrel Tablet Formulations
نویسندگان
چکیده
Clopidogrel bisulphate (anti-coagulant drug) is an enantio-selective chrial drug and needs to be monitored for the active form in tablet formulation. Hence, a stable tablet formulation was developed for clopidogrel using two different disintegrants of LHPC (to match as closely as possible to innovator tablet) and PVPP XL. Tablets were evaluated for stability analysis using validated analytical methods. The results showed similar drug release profile and assay on stability. Clopidogrel R-isomer was detected in both LHPC and PVPP XL containing tablet formulations and it was found to be less than 2.5% after six months stability study under accelerated conditions which is simulation of three years storage period
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