A GC–ECD Method for Analysis of Prasugrel in Bulk and Pharmaceutical Dosage Forms
DOI:
https://doi.org/10.37285/ijpsn.2015.8.1.6Abstract
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.
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Keywords:
GC-ECD, Pharmaceutical dosage forms, Prasugrel, Validation
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Alexopoulos D, Dimitropoulos G, Davlouros P, Xanthopoulou I, Kassimis G, Stavrou EF, Hahalis G and Athanassiadou A (2011). Prasugrel Overcomes High On-Clopidogrel Platelet Reactivity Post-Stenting More Effectively than High Dose (150 mg) Clopidogrel. Cardio Vascular Interventions 4(4): 403-410.
Angiolillo DJ, Saucedo JF and DeRaad R (2010). Increased Platelet Inhibition after Switching from Maintenance Clopidogrel to Prasugrel in Patients with Acute Coronary Syndromes. J Am CollCardiol. 56(13): 1017-23.
Baker WL and White CM (2009). Role of Prasugrel, A Novel P2Y12 Receptor Antagonist, in the Management of Acute Coronary Syndromes. AmJ Cardiovascular Drugs 9(4): 213-229.
Biondi-Zoccai G, D'Ascenzo F, Abbate A, Agostoni P and Modena MG (2011). Agreement between Adjusted Indirect Comparison And Simplified Networkmeta Analyses on Prasugrel and ticagrelor (Reply to Passaro et al. — Int J Cardiol 2011). Int J Cardiology 151(2): 228-9.
Blair PE, Kurihara A and Goldberg MJ (2007). The Disposition of Prasugrel, a Novel Thienopyridine, in Humans. J Cardiovascular Pharmacol, 35(7): 1096-110.
Borole TC, Mehendre R, Damle MC and Bothara KG (2010). Development and Validation of Stability Indicating HPTLC Method for Determination of Prasugrel. J. Chem. Pharm. Res. 2(4): 907-913.
Daali Y, Ancrenaz V, Bosilkovska M, Dayer P and Desmeules J (2011). Ritonavir Inhibits the Two main Prasugrelbioactivation Pathways in vitro: A Potential Drug–Drug Interaction in HIV Patients. Metabolism: Clinical and Experimental 60(11): 1584-9.
Farid NA, McIntosh M, Garofolo F, Wong E, Shwajch A, Kennedy M, Young M, Sarkar P, Kawabata K, Takahashi M and Pang H (2007). Quantitative Determination of Clopidogrel Active Metabolite in Human Plasma by LC–MS/MS. Rapid Communications in Mass Spectrometry 21(2): 169-179.
FDA Drug Safety Communication: Reduced Effectiveness of Plavix (clopidogrel) in Patients who are Poor Metabolizers of the Drug. Drug Safety and Availability. Food and Drug Administration (United States). March 12, (2010).
Food and Drug Administration (United States). FDA Announces New Boxed Warning on Plavix: Alerts Patients, Health care Professionals to Potential for Reduced Effectiveness. Retrieved March 13, (2010).
Hashimoto M, Sugidachi A, Isobe T, Niitsu Y, Ogawa T, Jakubowski JA, and Asai F (2007). The Influence of P2Y12 Receptor Deficiency on the Platelet Inhibitory Activities of Prasugrel in a Mouse Model: Evidence for Specific Inhibition of P2Y12 Receptors by Prasugrel. J Biochemical Pharmacol 74(7): 1003-1009.
Niitsu Y, Sugidachi A, Ogawa T, Jakubowski JA, Hashimoto M, Isobe T, Otsuguro K, and Asai F (2008). Repeat Oral Dosing of Prasugrel, a Novel P2Y12 Receptor Inhibitor, Results in Cumulative and Potent Antiplatelet and Antithrombotic Activity in Several Animal Species. Eur J Pharmacol 35(6): 593-618.
O'Riordan M. Switching from Clopidogrel to Prasugrel further Reduces Platelet Function.
Payne CD and John T (2007). Increased Active Metabolite Formation Explains the Greater Inhibition with Prasugrel Compared to High-dose Clopidogrel. J Cardiovascular Pharmacol 50(5): 555-562.
Prabahar AE, Rao NR, Rao KRS, and Kumar PV (2011). Method Development and Validation for the HPLC Potency Assay of Prasugrel Tablets. J Pharmacy Res 4(4): 980-982.
Small DS, Payne CD, Kothare P, Yuen E, Natanegara F, Loh MT, Jakubowski JA, Lachno DR, Li YG, Winters KJ, Farid NA, Ni L, Salazar DE, Tomlin M and Kelly R (2010). Pharmacodynamics and Pharmacokinetics of Single Doses of Prasugrel 30 mg and Clopidogrel 300 mg in Healthy Chinese and White Volunteers: An Open-Label Trial. J ClinTherap 32(2): 365-379.
Wiviott SD, Braunwald E and McCabe CH (2007). Prasugrel Versus Clopidogrel in Patients with Acute Coronary Syndromes. N. Engl. J. Med. 357(20): 2001-15.
