Analytical method development and validation of prasugrel in bulk and its pharmaceutical formulation using the RP-HPLC method

PURPOSE: 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. MATERIALS AND METHODS: The HPLC separation was carried out by reverse phase chromatography on an inertsil ODS-3V column (5 μm; 250 × 4.6mm(2)) with a mobile phase composed of 0.02 M potassium dihydrogen orthophosphate, 0.02 M dipotassium hydrogen orthophosphate in water:acetonitrile (30:70 v/v) in isocratic mode at a flow rate of 1 ml/min. The detection was monitored at 210 nm. RESULTS: The calibration curve for prasugrel was linear from 100 to 600 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 0.25 μg/ml and 0.75 μg /ml, respectively. Accuracy (recoveries: 99.8–101.2%) and reproducibility were found to be satisfactory. CONCLUSION: The proposed method is simple, fast, accurate, and precise for the simultaneous quantification of prasugrel in the dosage form, bulk drugs as well as for routine analysis in quality control.