Extractive Spectrophotometric Methods for determination of Prasugrel Hydrochloride in Pharmaceutical Formulations using some Acidic Triphenylmethane Dyes

摘要

Four simple and sensitive extractive spectrophotometric methods have been described for the assay of prasugrel hydrochloride either in pure form or in pharmaceutical formulations. The developed methods involve formation of coloured chloroform extractable ion-pair complexes of the drug with bromothymol blue (BTB), bromophenol blue (BPB), bromocresol green (BCG) and Bromocresol purple (BCP) in acidic medium. The extracted complexes showed absorbance maxima at 412 nm for all four methods. Beer's law is obeyed in the concentration range 4.0-40 μg/mL for all four methods. The effects of concentration of dye, pH, and interference of excipients have been studied and optimized. The limits of detection and quantification have been determined for four methods. All the four methods have been validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial tablets and results of analysis were validated statistically through recovery studies.