Stability Indicating RP-HPLC method for the determination of Prasugrel in bulk as well as in Pharmaceutical formulation

This study was designed to develop and validate a simple, sensitive, precise, specific and stability indicating reverse phase high-performance liquid chromatographic (HPLC) method for the determination of Prasugrel in bulk and its tablet dosage form. The HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 x 150mm, 5 μm) with a mobile phase composed of Potassium Dihydrogen Phosphate [pH was adjusted to 3.0 by using Orthophosporic Acid] and Acetonitrile in the ratio of 40:60 v/v in isocratic mode at a flow rate of 1.0 ml/min. The run time was 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 to 60 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. Prasugrel was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Peak homogeneity data of prasugrel was obtained using photodiode array detector in the stressed sample chromatograms, which demonstrated the specificity of the method for the estimation in presence of degradants. The present work was undertaken with the aim to develop and validate a rapid and consistent stability indicating 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. Overall, the proposed method was found to be suitable and accurate for quantitative determination and stability study of prasugrel in pharmaceutical dosage form.