Jornal de Carcinogênese e Mutagênese

Abstrato

Comparative Quality Evaluation of Different Brands of Clopidogrel Tablet Available in Bangladesh

MD Naimur Rehman

This study aims to assess the quality parameters of Clopidogrel tablets from different manufacturers available in the Bangladeshi market. Clopidogrel is a potent antiplatelet and antithrombotic drug. Clopidogrel has been approved and marketed globally with the primary indication being to reduce atherosclerotic events in patients with several comorbid conditions due to stroke, myocardial infarction and cardiovascular disease. The aim and the objective of our present study are to evaluate the quality parameters of some marketed Clopidogrel tablet and to compare the parameters among them. To assess the quality, three different marketed Clopidogrel 75 mg tablet are selected and invitro dissolution test, potency, disintegration time are carried out. Other general quality parameters of these tablets like weight variation, hardness, friability are also determined according to established protocols. All the brands comply the requirements of United State Pharmacopoeia as they show acceptable weight variation range. Friability of all brands is less than 1%. No significant differences are found in disintegration time as they disintegrate within 15 minutes. In case of dissolution profile all brands show better dissolution time as they release more than 75% of drug in 45 minutes. The hardness of one brand is within the range 40-60N. The limitation of the potency must be within 95- 105%. All three brands meet this specification. This study suggests that most commercially available Clopidogrel tablets in Bangladesh maintain the quality and comply with the USP specifications which are essential for better therapeutic activity of this antiplatelet drug.