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A Validated Non-Aqueous Potentiometric Titration Method for Quantitative Determination of Clopidogrel Bisulphate from Pharmaceutical Preparation


Affiliations
1 Department of Chemistry, D.G. Ruparel College, Mahim, Mumbai 400016, India
     

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A simple precise, rapid accurate and sensitive non-aqueous potentiometric titration method was developed for quantitative determination of clopidogrel bisulphate from pharmaceutical dosage form. The titration was carried out using standardized 0.1 N perchloric acid. The proposed method was found to be precise with % RSD <1 (n = 6). The method showed strict linearity (r2 > 0.9999) between 20 % to 100 % of 0.100 mg of drug substance weight. The percentage recovery of clopidogrel bisulphate in the optimized method was between 100.0 to 100.416 %. The method is also found to be rugged when checked by different analysts and using different lots of reagents and different makes of titrators.

Keywords

Clopidogrel Bisulphate, Perchloric Acid, Potassium Hydrogen Phthalate, Glacial Acetic Acid.
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  • A Validated Non-Aqueous Potentiometric Titration Method for Quantitative Determination of Clopidogrel Bisulphate from Pharmaceutical Preparation

Abstract Views: 331  |  PDF Views: 2

Authors

V. Rele Rajan
Department of Chemistry, D.G. Ruparel College, Mahim, Mumbai 400016, India
G. Rane Dattaprasad
Department of Chemistry, D.G. Ruparel College, Mahim, Mumbai 400016, India

Abstract


A simple precise, rapid accurate and sensitive non-aqueous potentiometric titration method was developed for quantitative determination of clopidogrel bisulphate from pharmaceutical dosage form. The titration was carried out using standardized 0.1 N perchloric acid. The proposed method was found to be precise with % RSD <1 (n = 6). The method showed strict linearity (r2 > 0.9999) between 20 % to 100 % of 0.100 mg of drug substance weight. The percentage recovery of clopidogrel bisulphate in the optimized method was between 100.0 to 100.416 %. The method is also found to be rugged when checked by different analysts and using different lots of reagents and different makes of titrators.

Keywords


Clopidogrel Bisulphate, Perchloric Acid, Potassium Hydrogen Phthalate, Glacial Acetic Acid.

References