Year 2018, Volume 7, Issue 3, Pages 87 - 92 2018-12-26

SORAFENİB ETKİN MADDESİNİN SPEKTROFOTOMETRİ YÖNTEMİYLE FARMASÖTİK PREPARATLARDA ANALİZİ
Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations

Onur Şenol [1]

18 158

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.  

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.

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Primary Language en
Subjects Health Care Sciences and Services
Journal Section Articles
Authors

Orcid: 0000-0002-0252-396X
Author: Onur Şenol (Primary Author)
Institution: ATATÜRK ÜNİVERSİTESİ
Country: Turkey


Bibtex @research article { balikesirsbd444872, journal = {Balıkesir Sağlık Bilimleri Dergisi}, issn = {2146-9601}, eissn = {2147-2238}, address = {Balıkesir University}, year = {2018}, volume = {7}, pages = {87 - 92}, doi = {}, title = {Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations}, key = {cite}, author = {Şenol, Onur} }
APA Şenol, O . (2018). Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations. Balıkesir Sağlık Bilimleri Dergisi, 7 (3), 87-92. Retrieved from http://dergipark.org.tr/balikesirsbd/issue/38838/444872
MLA Şenol, O . "Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations". Balıkesir Sağlık Bilimleri Dergisi 7 (2018): 87-92 <http://dergipark.org.tr/balikesirsbd/issue/38838/444872>
Chicago Şenol, O . "Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations". Balıkesir Sağlık Bilimleri Dergisi 7 (2018): 87-92
RIS TY - JOUR T1 - Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations AU - Onur Şenol Y1 - 2018 PY - 2018 N1 - DO - T2 - Balıkesir Sağlık Bilimleri Dergisi JF - Journal JO - JOR SP - 87 EP - 92 VL - 7 IS - 3 SN - 2146-9601-2147-2238 M3 - UR - Y2 - 2018 ER -
EndNote %0 Balıkesir Sağlık Bilimleri Dergisi Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations %A Onur Şenol %T Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations %D 2018 %J Balıkesir Sağlık Bilimleri Dergisi %P 2146-9601-2147-2238 %V 7 %N 3 %R %U
ISNAD Şenol, Onur . "Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations". Balıkesir Sağlık Bilimleri Dergisi 7 / 3 (December 2018): 87-92.