ESTIMATION OF PRASUGREL IN TABLET DOSAGE FORM BY RP­HPLC

Abstract

A simple, precise, rapid and accurate Reverse Phase HPLC method was developed for the estimation of Prasugrel in tablet dosage form. An Xterra
RP C18, 250x4.6 mm, column with 5 µm particle size and the mobile phase consisting of 0.03M K2HPO4 in water pH: 3.2 adjusted with Acetonitrile
(25:75). Acetonitrile in the isocratic mode was used. The flow rate was 1.0 ml/min and the effluents were monitored at 210 nm. The retention time
was 4.762 min. The detector response was linear in the concentration of 50‐600 mcg/mL for Prasugrel. The respective linear regression equation
being Y (158660.8513) = 10312.358x + 237007.9858 for Prasugrel. The Limit of Detection (LOD) and The Limit of Quantification (LOQ) were 2.5
mcg and 7.5 mcg respectively for Prasugrel. The percentage assay of Prasugrel was 99.93 %. The method was validated by determining its accuracy,
precision and system suitability. The results of the study showed that the proposed RP‐HPLC method is simple, rapid, precise and accurate, which is
useful for the routine determination of Prasugrel in bulk drug and in its pharmaceutical dosage forms.