Mon, 20 Nov 2017

Validation and Derivative Spectroscopy of Prasugrel HCl In Bulk and Formulation

R. Vani1*, B. Vijaya Kumar1, G. Krisha Mohan1, Anas Rasheed1

1.School of Pharmacy, Deccan Group of Institutions, Aghapura, Nampally, Hyderabad, India-500001


ABSTRACT

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 <2.0%. The proposed method was successfully applied for the assay of drug in pharmaceutical formulations. No interference was observed from common pharmaceutical excipients. Hence, the method herein described can be successfully applied in quality control of combined pharmaceutical dosage form.

Keywords: Prasugrel Hydrochloride, first-order derivative spectroscopy, zero order derivatization, pharmaceutical dosage form.


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