DIFFERENCE SPECTROPHOTOMETRIC ESTIMATION OF PRASUGREL HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

Authors

  • Desai Darshali Satishkumar
  • Walode Sanjay Gomaji

Keywords:

Prasugrel hydrochloride, Validation, ICH guidelines, Difference spectrophotometry

Abstract

A simple, precise and accurate difference spectroscopic method has been developed for the estimation of prasugrel hydrochloride in bulk and in pharmaceutical dosage form. The proposed method is based on the principle that prasugrel hydrochloride exhibits in two different chemical   forms that differs in the absorption spectra in basic and acidic medium. The absorbances were measured in acidic and basic solution separately against reagent blank. Prasugrel hydrochloride has exhibited maximum absorbance at 254 nm and 239 nm in acidic and basic solution respectively. Difference in absorbances between these two maxima was calculated to find out the amplitude. The amplitude plotted against concentration, showed linear response in the concentration range of 5-30 $ \mu $g/ml with the linear regression value 0.997. The proposed method was applied to pharmaceutical formulations and the common excipients present in the formulation did not interfere in the analysis of the drug. The method was validated as per ICH guidelines and statistical results of analysis were found to be satisfactory.

 

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Published

06-04-2012