Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2011 Vol: 3 Issue: 4

Development and validation of HPLC method for determination of prasugrel in bulk and its pharmaceutical formulation

Abstract

To develop and validate a simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method for the determination of prasugrel in bulk and tablet dosage forms. The HPLC separation was carried out by reverse phase chromatography on inertsil ODS-3V column (5μm; 250x4.6mm) with a mobile phase composed of 0.02M potassium dihydrogen orthophosphate, 0.02M dipotassium hydrogen orthophosphate in water: Acetronitrile (30:70 v/v) in isocratic mode at a flow rate of 1ml/min. The detection was monitored at 210nm. The calibration curve for prasugrel was linear from 100 to 600ng/ml. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of prasugrel in bulk and its tablet dosage forms. LOD and LOQ for prasugrel were found to be 0.25 μg/ml and 0.75 μg /ml respectively. Accuracy (recoveries: 99.8-101.2%) and reproducibility were found to satisfactory. The proposed method is simple, fast, accurate and precise for the simultaneous quantification of Prasugrel in dosage form, bulk drugs as well as for routine analysis in quality control.

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