Journal of Applied Pharmaceutical Science 01 (07); 2011: 172-175 ISSN: 2231-3354 Received on: 17-09-2011 Revised on: 22-09-2011 Accepted on: 25-09-2011 G. Usha Rani Department of P harmaceutical Chemistry, CM R College of Pharmacy, Medchal, Hyderabad, A .P. India B. Chandrasekhar Department of P harmacy, MLR College of Pharmacy, Hyderabad, A .P. India N. Devanna Department of A nalytical Chemistry, JNTU-A , Anantapur, A.P. India For Correspondence: G. Usha Rani Department of P harmaceutical Chemistry, CMR College of Pharmacy, M edchal, Hyderabad, A .P . India Phone No: +91-9966858687 Analytical method development and validation of prasugrel in bulk and its pharmaceutical formulation using HPLC G. Usha Rani, B. Chandrasekhar and N. Devanna ABSTRACT A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of prasugrel in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on inertsil ODS-3V (5μm; 250x4.6mm) with a mobile phase composed of 0.02M potassium dihydrogen orthophosphate, 0.02M dipotassium hydrogen orthophosphate in water: Acetronitrile (30:70 v/v) in isocratic mode at a flow rate of 1ml/min. The detection was monitored at 210nm. The calibration curve for prasugrel was linear from 100 to 600ng/ml. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of prasugrel in bulk and its tablet dosage forms. LOD and LOQ for prasugrel were found to be 0.25 µg/ml and 0.75 µg /ml respectively. Accuracy (recoveries: 99.8-101.2%) and reproducibility were found to satisfactory. Key words: Prasugrel, RP-HPLC Method, Reverse phase chromatography, Acetonitrile, Validation. INTRODUCTION Prasugrel chemically is 5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl] - 4, 5, 6, 7 - tetra Hydrothieno [3, 2-c] pyridin-2-yl acetate. It is a member of the thienopyridine class of ADP receptor inhibitors, like ticlopidine and clopidogrel. These agents reduce the aggregation of platelets by irreversibly binding to P2Y12 receptors. Prasugrel inhibits adenosine diphosphate– induced platelet aggregation more rapidly, more consistently, and to a greater extent than do standard and higher doses of clopidogrel in healthy volunteers and in patients with coronary artery disease (Borole et al, 2010). Fig 1: Chemical structure of Prasugrel. Literature survey revealed that some analytical methods like LC-MS (Tian et al., 2007; Farid et al., 2007) have been reported