Author/Authors :
Babaee, Tahereh Department of Drug and Food Control - Faculty of Pharmacy - Tehran University of Medical Sciences , Fazeli, Ahmad The Institute of Pharmaceutical Sciences (TIPS) - Tehran University of Medical Sciences, Tehran, Iran , Hashemi-Najafabadi, Sameereh Biomedical Engineering Group - Faculty of Chemical Engineering - Tarbiat Modares University, Tehran , Rastegar, Hosein Food and Drug Control References Laboratory - Food and Drug Organization - Ministry of Health and Medical Education, Tehran , Mohammadi, Ali The Institute of Pharmaceutical Sciences (TIPS) - Tehran University of Medical Sciences, Tehran, Iran , Khoshayand, Mohammad Reza The Institute of Pharmaceutical Sciences (TIPS) - Tehran University of Medical Sciences, Tehran, Iran , Fazeli, Mohammad Reza The Institute of Pharmaceutical Sciences (TIPS) - Tehran University of Medical Sciences, Tehran, Iran , Alebouyeh, Mahmoud Department of Molecular Biology - Food and Drug Control Reference Laboratory, Food and Drug Laboratory Research Center
Abstract :
Recombinant plasminogen activator (reteplase) is a third generation thrombolytic agent which has been used on coronary artery thrombosis and acute myocardial infarction. Clot lysis assay is usually considered as a unique method to evaluate biological activity of reteplase. In this study biological activity of reteplase was determined by APTT (activated partial thromboplastin time) lysis method. Validity of this method was evaluated in comparison with reference method, clot lysis time assay. Results of APTT lysis test showed good reproducibility (relative standard deviation (RSD) 3-5% for within day analysis and 4-7% for between day analysis), and accuracy (101.3-102.7%). APTT lysis responses were linear in range of 0.001-0.1 mg/mL reteplase. Therefore, APTT lysis method is applicable for biological activity determination of reteplase. Although more comprehensive studies are required to approve this test as a reference method, APTT lysis method seems to be valuable to receive more attention due to advantages of technical simplicity, sensitivity, applicability, and cost efficiency.
Keywords :
Recombinant reteplase , Clot lysis , APTT lysis test , Validation
