İlaç endüstrisinde kullanılan bazı analitik metodların geliştirilmesi
Küçük Resim Yok
Tarih
2007
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Trakya Üniversitesi
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
`İlaç Endüstrisi'nde Kullanılan Bazı Analitik Metodların Geliştirilmesi' isimli doktora tezi, Trakya Üniversitesi Kimya Bölümü Analitik Kimya anabilim dalında ve Fen Bilimleri enstitüsü kapsamında hazırlanmıştır. İlaç endüstrisinde kalite kontrolde kullanılan analitik metodların güvenli, doğru ve tekrarlanabilir olması gerekmektedir. Kullanılan malzemelerin pahalı olması sebebi ile (aktif madde, reaktif, işçilik maliyeti) analitiksel metodların ucuz ve kısa analiz sürelerinin olması istenmektedir. Bu amaç doğrultusunda 3 ayrı çalışma yapılacaktır; 1) Sildenafil Citrate aktif maddesini içeren bir film kaplı tablet için metilen klorür kalıntı çözücü miktar tayini metodu geliştirilmiştir. 2) Valacyclovir HCl aktif maddesini içeren bir ilaç ürünü için, miktar ve ilgili bileşikler analiz metodu geliştirililmiştir. 3) Bir ilaç ürünü, aktif madde olarak Tiyokolşikosid ve koruyucu olarak da Metil Paraben ve Etil Paraben içermektedir. Bu çalışmada, Tiyokolşikosid, Metil Paraben ve Etil Parabeni analiz eden 2 farklı metod birleştirilerek geliştirilmiştir. Yukarıda bahsedilen 3 ayrı çalışmada da İlaç Endüstrisi'nde kullanılan `Metod Doğrulama Yöntemi'kullanılmış olup, güvenilir ve hassas sonuçlar elde edilmiştir. Buna ilaveten mevcutta kullanılan metodlarla da aynı numuneleri analiz ederek doğrulaması yapılmıştır. ANAHTAR KELİMELER: HPLC , GC, Metod Doğrulama, Metilen Klorür, Valacyclovir, Acyclovir, Guanine, Tiyokolşikosid, Metil Paraben, Etil Paraben
The doctora thesis which is named `The development of some analytical methods used in drug industry? was prepared within the Analytical Chemistry Department of the Science Instituet of the University of Trakya. The used analytical methods in drug industry have to be accurate, precise and must be repeatable. Because of the high cost of the materyal, ( active materyal, reagent and worker price) the analytical methods are supposed to be cheap and must have a short analyzing time. For this purposes 3 different study will be performed ; 1) For a film coated tablet which contains of Sildenafil Citrate active materyal, an residual solvent assay method of Methylene Chloride was developed. 2) For a drug product that contains of Valacyclovir HCl active materyal, the assay and related substances analysis method was developed. 3) A drug product contains active incredient that is Thiocolchicoside and preservative materyals that are Methyl Paraben and Ethyl Paraben. In this study, the 2 different assay methods that are analyzed the Thiocolchicoside, Methyl Paraben, Ethyl Paraben materyals were combined and developed to one assay method. In 3 different study that above mentioned were used `Method Validation Procedure in Drug Industry?, reliable and sensitive results were obtained. In addition, the same samples were analyzed with exist methods and so the results are accurate. KEY WORDS: HPLC, GC, Method Validation, Methylene Chloride, Valacyclovir, Acyclovir, Guanine, Thiocolchicoside, Metyl Paraben, Ethyl Paraben
The doctora thesis which is named `The development of some analytical methods used in drug industry? was prepared within the Analytical Chemistry Department of the Science Instituet of the University of Trakya. The used analytical methods in drug industry have to be accurate, precise and must be repeatable. Because of the high cost of the materyal, ( active materyal, reagent and worker price) the analytical methods are supposed to be cheap and must have a short analyzing time. For this purposes 3 different study will be performed ; 1) For a film coated tablet which contains of Sildenafil Citrate active materyal, an residual solvent assay method of Methylene Chloride was developed. 2) For a drug product that contains of Valacyclovir HCl active materyal, the assay and related substances analysis method was developed. 3) A drug product contains active incredient that is Thiocolchicoside and preservative materyals that are Methyl Paraben and Ethyl Paraben. In this study, the 2 different assay methods that are analyzed the Thiocolchicoside, Methyl Paraben, Ethyl Paraben materyals were combined and developed to one assay method. In 3 different study that above mentioned were used `Method Validation Procedure in Drug Industry?, reliable and sensitive results were obtained. In addition, the same samples were analyzed with exist methods and so the results are accurate. KEY WORDS: HPLC, GC, Method Validation, Methylene Chloride, Valacyclovir, Acyclovir, Guanine, Thiocolchicoside, Metyl Paraben, Ethyl Paraben
Açıklama
Doktora
Anahtar Kelimeler
Kimya, Chemistry
