Validation and Derivative Spectroscopy of Prasugrel HCl In Bulk and Formulation

This study describes the development and validation for the determination of Prasugrel Hydrochloride in bulk and pharmaceutical dosage form by the first-order derivative UV spectroscopy method. The quantification was achieved by the first-order derivative spectroscopy method at 248 nm over the concentration range of 5-25 μg/ml for estimation of Prasugrel Hcl (r2=0.9993) keeping methanol as solvent in zero order derivatization and same 5-25 μg/ml for estimation of Prasugrel Hcl (r2=0.9981) in methanol upon first order derivatization. Procedure does not require prior separation of components from the sample. LOD values for Prasugrel Hclwas found to be 0.591μg/mL for zero order derivatization and upon first order derivatization 0.165 μg/mL. LOQ values for Prasugrel Hclwas found to be 1.970 μg/mL for zero order derivatization and upon first order derivatization0.55 μg/mL. The results of analysis have been validated statistically and recovery studies carried out in the range 50-150% to confirm the accuracy of the proposed method. The relative standard deviation was found to be