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

Yıl 2018, Cilt: 7 Sayı: 3, 87 - 92, 26.12.2018

Onur Şenol

Öz

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.

Anahtar Kelimeler

Validation, Sorafenib, Pharmaceutical Formulation

SORAFENİB ETKİN MADDESİNİN SPEKTROFOTOMETRİ YÖNTEMİYLE FARMASÖTİK PREPARATLARDA ANALİZİ

Öz

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.  

Anahtar Kelimeler

Validasyon, Sorafenib, Farmasötik Formülasyon

Kaynakça

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