TITLE

STABILITY INDICATING METHOD FOR QUANTITATION OF PRASUGREL HYDROCHLORIDE IN PRESENCE OF ITS DEGRADATION PRODUCTS

AUTHOR(S)
Desai, Darshali S.; Barmecha, Bharati S.; Walode, Sanjay G.
PUB. DATE
October 2012
SOURCE
International Journal of Pharmacy & Technology;Oct2012, Vol. 4 Issue 3, p4711
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
A stability indicating HPLC assay method has been developed and validated for the estimation of prasugrel hydrochloride in bulk and pharmaceutical dosage form. A RP-HPLC isocratic separation was achieved on C18 column (250×4.6 mm, 5μm) utilizing a mobile phase comprising of methanol and acetonitrile in the ratio of 90: 10 (v/v) and the eluents from the column were detected using a variable wavelength detector at 240 nm. The stress testing of prasugrel hydrochloride was carried out under acidic, alkaline, neutral hydrolysis, oxidation, photolytic and thermal degradation (dry heat) conditions and prasugrel hydrochloride was well resolved from its degradation products. The proposed method has permitted the quantification of prasugrel hydrochloride in the linearity range of 10-160 μg/ml and the flow rate was maintained at 1ml/min. The column was maintained at ambient temperature and the complete separation was achieved for prasugrel hydrochloride with all degradation products in an overall analytical run time of approximately 15 min. The retention time of prasugrel hydrochloride was found to be 3.78 min. The method was validated as per ICH guidelines.
ACCESSION #
85249755

 

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