TITLE

STABILITY INDICATING HPLC DETERMINATION OF CLOPIDOGREL BISULFATE IN PHARMACEUTICAL DOSAGE FORMS

AUTHOR(S)
Kurien, Jose; Jayasehar, P.
PUB. DATE
January 2013
SOURCE
Pharmacie Globale;Jan2013, Vol. 4 Issue 1, p1
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
A simple, selective, precise and stability indicating high performance liquid chromatographic (HPLC) method of analysis of Clopidogrel bisulfate in pharmaceutical dosage form was developed and validated. The chromatographic conditions comprised of a reversible phase C18 column (250 x 4.6 mm, 5µ ) with a mobile phase consisting of a mixture of acetonitrile and acetic acid (0.1% aqueous solution) in the ratio of 85:15. Flow rate was 1ml/min. Detection was carried out at 220nm. The retention time of Clopidogrel was 7.3min. Clopidogrel was subjected to acid and alkali hydrolysis, oxidation, photochemical and thermal degradation. The linear regression analysis data for the calibration plot showed good linear relationship in the concentration range of 1 - 100 µg/ml. The value of correlation coefficient, slope and intercept were 0.99951, 25.61 and -14.12 respectively. The method was validated for precision, accuracy, ruggedness and robustness. The drug undergoes degradation under acidic, basic, photochemical and thermal degradation conditions. All the peaks of degraded products were resolved from the active pharmaceutical ingredient with significant different retention times. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.
ACCESSION #
87977557

 

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