Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations

Abstract

Sorafenib  is one of the most  preffered kinase inhibitor drug that formerly approved in order to apply on therapy for primary kidney cancer (advanced renal cell carcinoma). In addition to this, this drug get  allowance for the  treatment of primary liver cancer (hepatocellular carcinoma), and radioactive iodine resistant advanced thyroid carcinoma. This proposed work is achieved to suggest different procedure for determination of sorafenib in pharmaceutical formulations. In order to carry out the study, reference standard samples were kindly obtained and a working concetrations were prepared in methanol ( 0.5 – 25 µg/mL) including 0.1 M HCl. All measurements were organised via UV-Vis spectrophotometer at 264 nm wavelength. Developed method was validated following ICH guideline. Precision and accuracy values for proposed method was found to be straightforwardly satisfactory whose values were better than 4% for both intra-day and inter day assays (n=6). Linearity was succesively provided between working concentration and corelation coefficien that were calculated to be 0.9966. After all succesful validation steps, method was applied to real pharmaceutical samples which kindly purchased by the local pharmaceutical store (Nevaxar). Analytical recovery study of the drug were calculated via standard addition method method. Three different quality control solutions were used to perform proposed study. To conclude, developed and validated method was succesively applied on real samples by getting satisfactory results.

Keywords

• Validation,Sorafenib,Pharmaceutical Formulation

SORAFENİB ETKİN MADDESİNİN SPEKTROFOTOMETRİ YÖNTEMİYLE FARMASÖTİK PREPARATLARDA ANALİZİ

Abstract

Sorafenib en fazla kullanılan kinaz inhibitör ilaçlarındandır ve ilk olarak böbrek kanseri tedavisi için onay almıştır. Buna ek olarak ilaç karaciğer ve tiroid kanseri tedavisinde de kullanılmaktadır. Önerilen çalışma sorafenibin farmasötik preparatlarda tayinine yönelik yeni bir yöntemin geliştirilmesini hedeflemektedir. Çalışmayı yürütmek üzere, referans standart numuneler temin edilip 0.5 – 25 µg/mL derişim aralığında 0.1 M HCl içeren metanol çözeltisinde hazırlanmıştır.Bütün çalışmalar 264 nm dalga boyunda UV-Görünür Bölge spektrofotometre cihazıyla yapılmıştır. Geliştirilen yöntem ICH kılavuzuna uygun olarak valide edilmiştir.Doğruluk ve kesinlik değerlerinin hem gün içi hem de günler arası verileri %4’ten daha iyi bulunmuştur. Yöntem kalibrasyon çözeltilerine bakıldığında lineerdir ve korelasyon katsayısı 0.9966 olarak hesaplanmıştır. Validasyon çalışması başarıyla tamamlandıktan sonra yöntem gerçek farmasötik formülasyonlar üzerinde uygulanmıştır ve bunun için Nevaxar preparatları yerel eczanelerden temin edilmiştir. Analitik geri kazanım çalışmaları standart ekleme yöntemine göre yapılmıştır. Üç farklı kalite kontrol çözeltisi bu çalışmalarda kullanılmıştır. Sonuç olarak geliştirilen ve geçerlilik testleri yapılan yöntemin farmasötik preparatların miktar analizinde başarıyla uygulanabilir olduğu yapılan çalışmalar sonucunda gözlenmiştir.  

Keywords

• Validasyon,Sorafenib,Farmasötik Formülasyon

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