Spectrophotometric Method Development and its Validation for Estimation of Prasugrel HCl in Bulk and Pharmaceutical Formulations

Prasugrel is an anti-platelet agent of the thieno-pyridine class approved by FDA in July 2009 is a Prodrug with restricted prescribing. A new visible spectrophotometric method has been developed and validated for the estimation of Prasugrel hydrochloride in bulk and pharmaceutical formulations. The method makes use of ion pair complex formation between drug and bromophenol blue (BPB). Bromophenol blue and 0.1 H₂SO₄ were used for the Spectrophotometric analysis of Prasugrel HCl in its pure and its dosage form. The absorbance of the complex formed, by Bromophenol blue and the drug was found maximum on wavelength 421 nm and for 0.1 H₂SO₄ at the wavelength 223 nm against the corresponding blank. Both the methods were found to be simple, precise, and rapid for detection of Prasugrel hydrochloride and can be conveniently adopted for routine analysis of Prasugrel hydrochloride.