Öz
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.
Teşekkür
Bu çalışmada, tez konumu belirleyen, çalışmalarımı yöneten, çalışmalarımın her aşamasında değerli katkılarını gördüğüm rahmetli hocam Prof. Dr. Tuncel ÖZDEN’e teşekkür ve şükranlarımı sunar, cenab-ı haktan rahmet dilerim. Mekanın cennet olsun hocam…
Kaynakça
- Akgün, H. , Balkan, A., Bilgin, A.A., Çalış, Ü. , Dalkara, S., Erdoğan, H. , Erol, D.D., Ertan, M., Özkanlı, F., Palaska, E., saraç, S., Şafak,C.: Farmasötik Kimya, Cilt l, Irmak Matbaası, Ankara. (2000).
- Al-Momani, F.: Determination of Nabumetone and its Major Metabolite in Plasma and Tablet Formulations by Reverse- Phase HPLC, Analytical Letters, 30(14), 2485-2492. (1997).
- Bartsch, H., Eiper, A., Kopelent-Frank, H., Stability İndicating Assays fort he determination of Piroxicam-compartison of methods, J. Pharm. Biomed.Anal., 20(3), 531-541.(1999)
- Bayliss, M.K., Little, D., Mallett, D.N., Plumb, R.S.: Parallel Ultra- High Flow Rate Liquid Chromotography With Mass Spectrometric Dedection Using A Multiplex Elecreosprey Source For Direct Sensitive Determmination Of Pharmaceutical İn Plazma At Exremly High Throughput, Rapid Commun. Mass Sprectrom., 14(21) ,2039-2045.(2000).
- Boyle, E.A., Mangan, F.R.: The Effect of a Noval, Non-Steroidal Anti-Inflammatory Compound, Nabumetone (BRL 14777), on Cellular Infiltration into 24-hour Polyvinyl Sponge Implayns in the Rat, Compared with some Steroidal and Non-Steroidal Anti-Inflammatory Drugs, J. Pharm. Pharmacol., 34. 570-575. (1982)
- British Phamacopoeia, 1-11, Crown Copyright, London, 912-913. (1998).
- Brooks, P.: Use and Benefits of Nonsteroidal Anti-inflammatory Drugs, The American Journal of Medicine, 104 (3A), 9S-13S. (1988).
- Duncan, M.W.: Bİomedical Mass Spectrometry Unit, Universty of New South Wales, Sydney, Australia, NATO ASI Ser.,
- C504 (Selected Topics in Mass Spectrometry in Biomoleculer Sciences), 103-119, Kluwer Academic Publishers Review Sec.9. (1997).
- European Pharmacopoeia- Supplement, Council of Europe, Strasbourg, 1157- 1158. (2001). Goudie, A.C., Gaster, L.M., Lake, A W-, Rose, C.J., Freeman, P.C., Hughes, B.O.: 4-(6-Methoxy-2 naphtyl)butan-2-one and Related Analogues, a Novel Structural Class of Anti-lnflammattory Compounds, Joumal of Medicinal Chemistry, 21 (12), 1260-1264. (1978).
- Kayaalp, S.O.: Rasyonel Tedavi Yönünden Tıbbi Farmakoloji, Sekizinci baskı, 2. Cilt, Hacettepe-Taş Kitapçılık Ltd. Şti., Ankara. (1998).
- Makhija, S.N., Vavia, P.R.: Stability Indicating HPTLC Method for the Simultaneous Determination of Pseudoephedrine and Cetirizine in Pharmaceutical Formulations, J. Pharm. Biyomed. Anal., 25 (3-4), 663-667,(2001).
- Mandell, B.F.: General Tolerability and Use of Nonsteroidal Anti- Inflammattory Drugs, The American Joumal of Medicine, 107 (6A), 72S-76S. (1999).
- Nimesulide from Pharmaceutical Dosage Forms, J.Pharm. Biomed.Anal., 25 (3-4), 685-688. (2001).
- Novakovic, J., Nesmerak, K., Nova, H., Filka, K.: An Hptlc Method For The Determination and The Purity Control Of Ciprofiloxacin HCl in Coated Tablets, j. Pharm. Biyomed. Anal., 25 (5-6),957-964.(2001).
- Novakovic, J.: Validation of a High-performance Thin Layer Chromatographic Method for trace analysis for some generic drugs affercting gastrointestinal function, J.AOAC Int., 83(6), 1468-1473.(2000)
- Noyanalpan, N., Özden, T.: Quantative Determination of Meprobamate by NMR in commercial Oreparations Marketed in Turkey, Ank. Ecz. Fak. Mec., 7(2), 189-195. (1977).
- Özden, S., Özden, T., Yalçın, İ., Noyanalpan, N.: İndometasin’in Nükleer Manyetik Rezonans Spektroskopisi ile Yeni Bir Miktar Tayini Yöntemi, FABAD J. Pharm. Sci., 8, 142-9. (1983)
- Patravale, V.B., D’Souza S., Narkar, Y.: HPTLC Determination of Nimesulide from Pharmaceutical Dosage Forms, J.Pharm. Biomed.Anal., 25 (3-4), 685-688. (2001).
- Pouchert, C.J., Campbell, J.R.: The Aldrich Library of NAR Spectra., Aldrich Chemical Company, USA. (1974).
- Schiffman, S.S., Zervakis, J., Westall, H.L., Graham, B.G., Metz, A-, Bennett, J.L., Heald, A.E.: Effect of Antimicrobial and Anti-inflammatory Medications on the Sense of Taste, Physiology & Behavior, 69, 413-424. (2000).
- Simultaneous Determination of Pseudoephedrine and Cetirizine in Pharmaceutical Formulations, J. Pharm. Biyomed. Anal., 25 (3-4), 663-667,(2001).
- Skoog, D.A., Holler, F.J., Niemann, T.A.: Princiles of İntrumental Analyses, Fifth Edition, Harcourt Brace & Company, USA. (1998).
- Turzcan, J.W., Kram, T.C.: Determination of Meprobamate in tablets by NMR J: Pharm.Sci. 56(12), 1643-6. (1967).
- USP 23, The United states Pharmacopeia, Rand McNally (1995)
- Wolff, J.C., Hawtİn, P.N., Monte, S., Balogh, M., Jones, T.: The use of Particle Beam Mass Spectrometry for the Measurement of Imputities in a Nabumetone Dıug Substance, Not Easily Amenable to Atmospheric Pressure Ionisation Techniques, Rapid Communications in Mass Spectrometry, 15, 265- 272. (2001).
Öz
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.
Anahtar Kelimeler
Kaynakça
- Akgün, H. , Balkan, A., Bilgin, A.A., Çalış, Ü. , Dalkara, S., Erdoğan, H. , Erol, D.D., Ertan, M., Özkanlı, F., Palaska, E., saraç, S., Şafak,C.: Farmasötik Kimya, Cilt l, Irmak Matbaası, Ankara. (2000).
- Al-Momani, F.: Determination of Nabumetone and its Major Metabolite in Plasma and Tablet Formulations by Reverse- Phase HPLC, Analytical Letters, 30(14), 2485-2492. (1997).
- Bartsch, H., Eiper, A., Kopelent-Frank, H., Stability İndicating Assays fort he determination of Piroxicam-compartison of methods, J. Pharm. Biomed.Anal., 20(3), 531-541.(1999)
- Bayliss, M.K., Little, D., Mallett, D.N., Plumb, R.S.: Parallel Ultra- High Flow Rate Liquid Chromotography With Mass Spectrometric Dedection Using A Multiplex Elecreosprey Source For Direct Sensitive Determmination Of Pharmaceutical İn Plazma At Exremly High Throughput, Rapid Commun. Mass Sprectrom., 14(21) ,2039-2045.(2000).
- Boyle, E.A., Mangan, F.R.: The Effect of a Noval, Non-Steroidal Anti-Inflammatory Compound, Nabumetone (BRL 14777), on Cellular Infiltration into 24-hour Polyvinyl Sponge Implayns in the Rat, Compared with some Steroidal and Non-Steroidal Anti-Inflammatory Drugs, J. Pharm. Pharmacol., 34. 570-575. (1982)
- British Phamacopoeia, 1-11, Crown Copyright, London, 912-913. (1998).
- Brooks, P.: Use and Benefits of Nonsteroidal Anti-inflammatory Drugs, The American Journal of Medicine, 104 (3A), 9S-13S. (1988).
- Duncan, M.W.: Bİomedical Mass Spectrometry Unit, Universty of New South Wales, Sydney, Australia, NATO ASI Ser.,
- C504 (Selected Topics in Mass Spectrometry in Biomoleculer Sciences), 103-119, Kluwer Academic Publishers Review Sec.9. (1997).
- European Pharmacopoeia- Supplement, Council of Europe, Strasbourg, 1157- 1158. (2001). Goudie, A.C., Gaster, L.M., Lake, A W-, Rose, C.J., Freeman, P.C., Hughes, B.O.: 4-(6-Methoxy-2 naphtyl)butan-2-one and Related Analogues, a Novel Structural Class of Anti-lnflammattory Compounds, Joumal of Medicinal Chemistry, 21 (12), 1260-1264. (1978).
- Kayaalp, S.O.: Rasyonel Tedavi Yönünden Tıbbi Farmakoloji, Sekizinci baskı, 2. Cilt, Hacettepe-Taş Kitapçılık Ltd. Şti., Ankara. (1998).
- Makhija, S.N., Vavia, P.R.: Stability Indicating HPTLC Method for the Simultaneous Determination of Pseudoephedrine and Cetirizine in Pharmaceutical Formulations, J. Pharm. Biyomed. Anal., 25 (3-4), 663-667,(2001).
- Mandell, B.F.: General Tolerability and Use of Nonsteroidal Anti- Inflammattory Drugs, The American Joumal of Medicine, 107 (6A), 72S-76S. (1999).
- Nimesulide from Pharmaceutical Dosage Forms, J.Pharm. Biomed.Anal., 25 (3-4), 685-688. (2001).
- Novakovic, J., Nesmerak, K., Nova, H., Filka, K.: An Hptlc Method For The Determination and The Purity Control Of Ciprofiloxacin HCl in Coated Tablets, j. Pharm. Biyomed. Anal., 25 (5-6),957-964.(2001).
- Novakovic, J.: Validation of a High-performance Thin Layer Chromatographic Method for trace analysis for some generic drugs affercting gastrointestinal function, J.AOAC Int., 83(6), 1468-1473.(2000)
- Noyanalpan, N., Özden, T.: Quantative Determination of Meprobamate by NMR in commercial Oreparations Marketed in Turkey, Ank. Ecz. Fak. Mec., 7(2), 189-195. (1977).
- Özden, S., Özden, T., Yalçın, İ., Noyanalpan, N.: İndometasin’in Nükleer Manyetik Rezonans Spektroskopisi ile Yeni Bir Miktar Tayini Yöntemi, FABAD J. Pharm. Sci., 8, 142-9. (1983)
- Patravale, V.B., D’Souza S., Narkar, Y.: HPTLC Determination of Nimesulide from Pharmaceutical Dosage Forms, J.Pharm. Biomed.Anal., 25 (3-4), 685-688. (2001).
- Pouchert, C.J., Campbell, J.R.: The Aldrich Library of NAR Spectra., Aldrich Chemical Company, USA. (1974).
- Schiffman, S.S., Zervakis, J., Westall, H.L., Graham, B.G., Metz, A-, Bennett, J.L., Heald, A.E.: Effect of Antimicrobial and Anti-inflammatory Medications on the Sense of Taste, Physiology & Behavior, 69, 413-424. (2000).
- Simultaneous Determination of Pseudoephedrine and Cetirizine in Pharmaceutical Formulations, J. Pharm. Biyomed. Anal., 25 (3-4), 663-667,(2001).
- Skoog, D.A., Holler, F.J., Niemann, T.A.: Princiles of İntrumental Analyses, Fifth Edition, Harcourt Brace & Company, USA. (1998).
- Turzcan, J.W., Kram, T.C.: Determination of Meprobamate in tablets by NMR J: Pharm.Sci. 56(12), 1643-6. (1967).
- USP 23, The United states Pharmacopeia, Rand McNally (1995)
- Wolff, J.C., Hawtİn, P.N., Monte, S., Balogh, M., Jones, T.: The use of Particle Beam Mass Spectrometry for the Measurement of Imputities in a Nabumetone Dıug Substance, Not Easily Amenable to Atmospheric Pressure Ionisation Techniques, Rapid Communications in Mass Spectrometry, 15, 265- 272. (2001).
Ayrıntılar
| Birincil Dil | Türkçe |
|---|---|
| Konular | Mühendislik |
| Bölüm | Makaleler |
| Yazarlar | |
| Yayımlanma Tarihi | 20 Mart 2020 |
| Yayımlandığı Sayı | Yıl 2020 |