DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF PRASUGREL HYDROCHLORIDE IN BULK AND IN PHARMACEUTICAL FORMULATIONS

Abstract

A new, simple, specific, accurate, precise, and rapid reverse phase high performance liquid chromatographic method was developed and validated for the determination of prasugrel Hydrochloride in pure and tablet dosage forms. The HPLC separation was carried out by reverse phase chromatography on Kromasil  C18 (100 x 4.6mm; 5μm) with a mobile phase consist of methanol  buffer (680mg potassium dihydrogen phosphate in 500 ml water, pH-2.1 adjusted with ortho phosphoric acid) in the ratio of 70:30 v/v delivered in isocratic mode at a flow rate of 0.8 ml/min. The prasugel Hydrochloride was quantified at 220nm. The retention time of Prasugrel Hydrochloride was 1.9 min. The developed method was validated according to ICH guidelines. The interday and intraday precision were found to be within limits. The developed method has adequate sensitivity and specificity for the determination of prasugrel Hydrochloride in bulk and its tablet dosage forms. Accuracy (recoveries: 98.92-101.19%) and reproducibility were found to satisfactory. The developed method was found to be cost effective and was successfully employed for the determination of Prasugrel Hydrochloride in various pharmaceutical preparations.