Nabumeton İçeren Tabletlerde Yeni Miktar Tayin Yöntemleri ve Diğer Yöntemlerle Karşılaştırması

Türkiye'de Relifex film tablet adı altında satılan ve non-steroidal antienflamatuvar etkili, romatoid artrit ve osteoartrit tedavisinde endike bir bileşik olan nabumetonun preparatlardaki miktarlarının tayini için yeni yöntemler geliştirilmiştir. Çalışmada, HPLC, HPTLC, 1H-NMR ve LC/MS yöntemleri olmak üzere dört yeni yöntem geliştirilmiş ve bulunan yöntemler ticari tabletlere uygulanmıştır. Dört ayrı yöntemin sonuçları istatistiksel olarak değerlendirilmiş ve kendi aralarında hassasiyet, çabukluk, kolay uygulanabilirlik ve ekonomik yönden karşılaştırılması yapılmıştır. Geliştirilen bu yeni yöntemler günümüzde rutin analizlerde uygulanan UV yönteminden daha hassas ve daha iyidir. Bu çalışmayla, ilaç sanayinde ve ilaçların piyasa ile ruhsat aşamasındaki kontrollerinde teknolojinin yakından takip edilmesi gerekliliği açıkça ortaya konulmaktadır. Kantitatif ilaç analizlerinde daha kesin sonuç veren, kolaylıkla uygulanabilen ve insan hatasının en aza indirgendiği yeni cihazları kullanmak ve birlikte getirdikleri modern teknolojilerle analizleri gerçekleştirmek kaçınılmazdır.

Anahtar Kelimeler:

Nabumeton, LC/MS, HPTLC, 1H-NMR

New Determination of Nabumetone-containing Tablets and Their Comparison with Other Methods

New methods have been developed to determine the amount of nabumetone in preparations sold under the commercial name "Relifex” in Turkey, to treat the symptoms related to the rheumatoid arthritis and osteoartritis as a non- steroidal anti-inflammatory drug. In this work, four different new methods, HPLC, HPTLC, 1H-NMR and LC/MS have been developed and applied to commercial tablets. The results of all these four different methods are compared and inter comparison of these results with respect to sensitivity, ease of applicability and the coşt are made between themselves. All these new methods developed are better and more sensitive than UV methods used in routine analysis nowadays. İn this study, it is obviously understood that the new techniques should be considered in controls and registration of the drugs. It is necessary to make the analysis by using modern techniques and to use new instrumentations to have more definite results in quantitative analysis and to make easy analytic applications and to decrease errors.

Keywords:

Nabumetone, LC/MS, HPTLC, 1H-NMR,

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