How to Cite
Abstract
Atherothrombotic complications - heart attack and stroke - are one of the main causes of disability and death of the world’s population. Therefore, the prevention and treatment of atherothrombosis is a necessary condition for prolonging the life of patients with cardiovascular system and improving the quality of life. A representative of the second generation of thienopyridines – Clopidogrel, is one of the most popular antiplatelet drugs in modern clinical practice. Clopidogrel 75 mg tablets under the brand name STAZEX are produced by the Georgian pharmaceutical enterprise “GMP”. Qualitative and quantitative determination of impurities in STAZEX is an actual issue, since it is a guarantee of its quality, therefore, effectiveness and safety. The authors determined individual and total impurities of clopidogrel in Stazex 75 mg tablets by high-performance liquid chromatography. As a result of determination of individual impurity and the sum of impurities, impurity A was found to be 1.2% (norm £ 1.2%). impurity b, - 0.5% (norm £ 0.5%). The impurity is 0.394% (norm £ 1.5). The use of the developed methodology is recommended for quality assurance and control of STAZEX and clopidogrel containing other tablets, as well as for scientific or practical research.
References
ლიპინკოტის ილუსტრირებული გამოცემა: ფარმაკოლოგია. მთარგმნელი და სამეცნიერო რედაქტორი თ. კეზელი. ივანე ჯავახიშვილის სახ. უნივერსიტეტის გამოცემა, 2017წ. 407-420
საინფორმაციო სამედიცინო სამსახური - http://www.mis.ge//
Antithrombotic Trialists Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients // BMJ. – 2002. – Vol. 324. – P. 71–86.
British Pharmacopeia 2021; page 2078-2080 5. Bundhoo S.S., Anderson R.A., Sagan E., Hassan N., Pinder A.G., Rogers S.C., Morris K., James P.E. Direct formation of thienopyridine-derived nitrosothiols—just add nitrite! Eur. J. Pharmacol.2011;670:534–540. doi: 10.1016/
j.ejphar.2011.09.02228.
CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE) // Lancet. – 1996. – Vol. 348. – P. 1329–1339. 21.
Heitzer T., Rudolph V., Schwedhelm E., Karstens M., Sydow K., Ortak M., Tschentscher P., Meinertz T., Böger R., Baldus S. Clopidogrel improves systemic endothelial nitric oxide bioavailability in patients with coronary artery disease: Evidence for antioxidant and antiinflammatory effects. Arterioscler. Thromb. Vasc. Biol. 2006;26:1648–1652.
Steg G., Bhatt D.L., Wilson P.W.F. et al., forthe REACH Registry Investigators. One-yearcardiovascular event rates
in outpatients with atherothrombosis. JAMA 2007;297:1197—206.
Tanaka A., Tomiyama H., Maruhashi T., Matsuzawa Y., Miyoshi T., Kabutoya T., Kario K., Sugiyama S., Munakata M., Ito H., et al. Physiological Diagnostic Criteria for Vascular Failure. Hypertension. 2018;72:1060–1071.
US Pharmacopeia USP43-NF38 2S 2021
Watanabe H., Domei T., Morimoto T., Natsuaki M., Shiomi H., Toyota T., Ohya M., Suwa S., Takagi K., Nanasato M., et al. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019; 321:2414–2427.