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Estimation of Clopidogrel in Bulk and Pharmaceutical Formulations


Affiliations
1 Dept of Pharma. Chemistry, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte-575018, Mangalore, India
     

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Four simple, sensitive, rapid and accurate methods have been developed for the estimation of Clopidogrel in bulk and pharmaceutical dosage forms. Method I was a HPLC method involving an isocratic elution of Clopidogrel in a column of Phenomenex C18, 250×4.6, 5 μ, using a mobile phase composition of acetonitrile and ammonium acetate buffer (85:15, v/v). The flow rate was 1.0 ml/min and the analyte monitored at 223 nm. Method II was based on the simultaneous estimation of Clopidogrel and Aspirin developed by determining the isoabsorptive point of both drugs by UV Spectroscopic. Method III was a colorimetric method based on the formation of red colored complex between Clopidogrel and vanillin in presence of concentrated sulphuric acid, which showed absorption maxima at 517n m for the routine analysis. In UV method IV clopidogrel showed linearity between 5-40 μg/ml at 235 nm. The proposed methods are optimized and validated as per the International Conference on Harmonization (ICH) guidelines.

Keywords

Clopidogrel, HPLC, Simultaneous UV, Colorimetry.
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  • Estimation of Clopidogrel in Bulk and Pharmaceutical Formulations

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Authors

J. Jane
Dept of Pharma. Chemistry, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte-575018, Mangalore, India
M. V. Jasminkumar
Dept of Pharma. Chemistry, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte-575018, Mangalore, India
D. Prasanth
Dept of Pharma. Chemistry, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte-575018, Mangalore, India

Abstract


Four simple, sensitive, rapid and accurate methods have been developed for the estimation of Clopidogrel in bulk and pharmaceutical dosage forms. Method I was a HPLC method involving an isocratic elution of Clopidogrel in a column of Phenomenex C18, 250×4.6, 5 μ, using a mobile phase composition of acetonitrile and ammonium acetate buffer (85:15, v/v). The flow rate was 1.0 ml/min and the analyte monitored at 223 nm. Method II was based on the simultaneous estimation of Clopidogrel and Aspirin developed by determining the isoabsorptive point of both drugs by UV Spectroscopic. Method III was a colorimetric method based on the formation of red colored complex between Clopidogrel and vanillin in presence of concentrated sulphuric acid, which showed absorption maxima at 517n m for the routine analysis. In UV method IV clopidogrel showed linearity between 5-40 μg/ml at 235 nm. The proposed methods are optimized and validated as per the International Conference on Harmonization (ICH) guidelines.

Keywords


Clopidogrel, HPLC, Simultaneous UV, Colorimetry.