Development and Validation of Rp-HPLC Method for the Estimation of Prasugrel in Bulk as Well in Pharmaceutical Dosages Form

This study was designed to develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (HPLC) method for the determination of Prasugrel in bulk and its tablet dosage forms.The HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 x 150mm, 5 mm) with a mobile phase composed Potassium Dihydrogen phosphate and the pH has been adjusted to 3.0 by Orthophosporic Acid & Acetonitrile in the ration of 40:60 v/v in isocratic mode at a flow rate of 1.0 ml/min.The run time has been maintained 5mins.The detection was monitored at 210 nm.The Accuracy was calculated and the % Recovery was found 99.0%-101.8%and reproducibility was found to be satisfactory .The calibration curve for Prasugrel was linear from 20 to60 µg/ml.The inter-day and intra-day 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.The limit of detection and limit of quantification for Prasugrel were found to be 0.07 µg/ml and 0.2 µg /ml respectively.The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC in which the peaks will be appear with a short period of time as per ICH guideline.The proposed method is simple, fast, accurate, and precise for the quantification of Prasugrel in the dosage form, bulk drugs as well as for routine analysis in quality control.