METHOD DEVELOPMENT AND VALIDATION OF CLOPIDOGREL DRUG IN THE DRUG SUBSTANCES AND DOSAGE FORM BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present work describes a validated reverse phase high performance liquid chromatographic method for estimation of Clopidogrel in the drug substances and dosage form. The quantification was carried out using Ultron ES OVM (150*4.6) mm, 5Âµm and mobile phase comprised of Buffer, Acetonitrile and in proportion of 70:30 %v/v. The flow rate was 1.0 ml/min and the eluent was monitored at 220 nm. The selected chromatographic conditions were found to effectively quantitate Clopidogrel at retention time of about 3.8 min. Linearity were found to be in the range of 11-75 Î¼g/ml. The percentage recoveries of all the drugs were found to be 99.3-101.1%. The proposed method was found to be fast, specific, accurate, precise, and reproducible and can be used for estimation of the Clopidogrel drugs.
Keywords: Clopidogrel, Reversed-phase HPLC.
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