Housheh et al: A GC-ECD Method for Analysis of Prasugrelin Bulk and Pharmaceutical Dosage Forms 1 Research Paper A GC–ECD Method for Analysis of Prasugrel in Bulk and Pharmaceutical Dosage Forms Samer Housheh 1* , Saleh Trefi 1 , Mohammad Haroun 2 and M. FawazChehna 1 1 Department of Quality Control and Pharmaceutical Chemistry, University of Aleppo, Syrian Arab Republic, and 2 Department of Quality Control and Pharmaceutical Chemistry, University of Tishreen, Syrian Arab Republic. Received July 8, 2014; accepted December 23, 2014 ABSTRACT Prasugrel is a novel ADP receptor inhibitor with antithrombotic properties. This paper proposes a new method for quantitative analysis of prasugrel in bulk and pharmaceutical dosage forms. The method used gas chromatography with electron-capture detection (GC– ECD). Chromatographic analysis was performed on an RTX-5 capillary column. Under the optimum conditions, good retention and peak response were achieved for prasugrel. The analytical method was fully validated by assessment of LOD and LOQ (0.24 μg/mL and 0.73 μg/mL), linearity (R = 0.997) over the range 0.5-2.5 μg/mL and extraction recovery (>98.7 %, with RSD below 1.0, for prasugrel spiked at 0.5, 1, 1.25, 2 and 2.5 μg/mL), the precision was 0.825% and the intermediate precision was 1.134%. The method required no clean-up of prasugrel before and after injection. It has been successfully used to determine prasugrel content in different commercial pharmaceutical dosage forms. KEYWORDS: GC-ECD; Pharmaceutical dosage forms; Prasugrel; Validation. Introduction Prasugrel chemically is 5-[2-cyclopropyl-1-(2-fluoro- phenyl)-2-oxoethyl]-4,5,6,7-tetra hydrothieno [3,2-c] pyridin-2-yl acetate Figure 1. Its empirical formula is C 20 H 20 FNO 3 S and its molecular weight is 373.442 g/mol. Fig. 1 Chemical structure of prasugrel. Prasugrel is a member of the thienopyridine class of ADP receptor inhibitors, like ticlopidine and clopidogrel (Baker and White, 2009). These agents reduce the aggregation ("clumping") 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 (Wiviott, 2007; FDA Drug Safety Communication, 2010). A pharmacodynamic study suggests that acute coronary syndrome (ACS) patients can be safely switched from clopidogrel to prasugrel and that doing so results in a further reduction in platelet function after one week (Angiolillo, 2010). When patients receive a loading dose of Prasugrel prior to switching from clopidogrel, the reduction in platelet function occurs within two hours. Literature survey revealed that only a few analytical methods like UV (Blair, 2007), LC-MS (Farid, 2007; Borole, 2010; Prabahar, 2011; Payne and John, 2007; Hashimoto, 2007), HPTLC (Small, 2010; Niitsu, 2008; Biondi-Zoccai, 2011) and HPLC (Alexopoulos, 2011; Daali, 2011) were reported for the analysis of prasugrel, but no research was done for its determination in raw materials and in pharmaceutical dosage form using GC- ECD. Hence, the purpose of this study was to develop sensitive, simple, rapid, precise, and accurate GC-ECD method for the estimation of prasugrel in raw materials and in pharmaceutical dosage forms in normal conditions and after performing stress studies under a variety of ICH recommended test conditions. However the method does not discuss the identity of the degradation products, the presented work only deals with method development and validation. This paper describes a new method for quantitative analysis of prasugrel in bulk and pharmaceutical dosage forms using gas chromatography with electron-capture detection (GC-ECD). Materials and Methods Chemicals and drugs: Working standard of prasugrel (PubChem CID: 6918456) was provided as a gift from Medico Laboratories, Syria and used without further International Journal of Pharmaceutical Sciences and Nanotechnology Volume 8  Issue 1  January – March 2015 MS ID: IJPSN-7-8-14-HOUSHEH