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

Year 2018, Volume: 7 Issue: 3, 87 - 92, 26.12.2018

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.

References

  • 1. Burris 3rd H, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. Journal of clinical oncology. 1997;15(6):2403-13.
  • 2. Debiec-Rychter M, Cools J, Dumez H, Sciot R, Stul M, Mentens N, et al. Mechanisms of resistance to imatinib mesylate in gastrointestinal stromal tumors and activity of the PKC412 inhibitor against imatinib-resistant mutants. Gastroenterology. 2005;128(2):270-9.
  • 3. Manning G, Whyte DB, Martinez R, Hunter T, Sudarsanam S. The protein kinase complement of the human genome. Science. 2002;298(5600):1912-34.
  • 4. Escudier B, Szczylik C, Eisen T, Stadler W, Schwartz B, Shan M, et al. Randomized phase III trial of the Raf kinase and VEGFR inhibitor sorafenib (BAY 43–9006) in patients with advanced renal cell carcinoma (RCC). Journal of Clinical Oncology. 2005;23(16_suppl):LBA4510-LBA.
  • 5. Wilhelm S, Carter C, Lynch M, Lowinger T, Dumas J, Smith RA, et al. Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nature reviews Drug discovery. 2006;5(10):835.
  • 6. Connock M, Round J, Bayliss S, Tubeuf S, Greenheld W, Moore D. Sorafenib for the treatment of advanced hepatocellular carcinoma. Health Technol Assess. 2010;14(Suppl 1):17-21.
  • 7. Curtit E, Thiery-Vuillemin A, Nguyen T, Heyd B, Pivot X, Di Martino V, et al. Complete histologic response induced by sorafenib in advanced hepatocellular carcinoma: a case report. Journal of Clinical Oncology. 2011;29(12):e330-e2.
  • 8. Awada A, Hendlisz A, Gill T, Munoz R, Bartholomeus S, de Valeriola D, et al., editors. Final results of a clinical and pharmacokinetic (PK) phase I study of the Raf kinase inhibitor BAY 43-9006 in refractory solid cancers: a promising anti-tumor agent. EUROPEAN JOURNAL OF CANCER; 2002: PERGAMON-ELSEVIER SCIENCE LTD THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND.
  • 9. Clark JW, Eder JP, Ryan D, Lathia C, Lenz H-J. Safety and pharmacokinetics of the dual action Raf kinase and vascular endothelial growth factor receptor inhibitor, BAY 43-9006, in patients with advanced, refractory solid tumors. Clinical Cancer Research. 2005;11(15):5472-80.
  • 10. Moore M, Hirte H, Siu L, Oza A, Hotte S, Petrenciuc O, et al. Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Annals of oncology. 2005;16(10):1688-94.
  • 11. Zhao M, Rudek MA, He P, Hafner F-T, Radtke M, Wright JJ, et al. A rapid and sensitive method for determination of sorafenib in human plasma using a liquid chromatography/tandem mass spectrometry assay. Journal of Chromatography B. 2007;846(1-2):1-7.
  • 12. Jain L, Gardner ER, Venitz J, Dahut W, Figg WD. Development of a rapid and sensitive LC–MS/MS assay for the determination of sorafenib in human plasma. Journal of pharmaceutical and biomedical analysis. 2008;46(2):362-7.
  • 13. Kalaichelvi R, Jayachandren E. UV spectrophotometric estimation of sorafenib in pure and tablet dosage form. Journal of pharmacy research. 2011;4(10):3705-6.
  • 14. Shimada M, Okawa H, Maejima T, Yanagi T, Hisamichi K, Matsuura M, et al. A quantitative HPLC-UV method for determination of serum sorafenib and sorafenib N-oxide and its application in hepatocarcinoma patients. The Tohoku journal of experimental medicine. 2014;233(2):103-12.

SORAFENİB ETKİN MADDESİNİN SPEKTROFOTOMETRİ YÖNTEMİYLE FARMASÖTİK PREPARATLARDA ANALİZİ

Year 2018, Volume: 7 Issue: 3, 87 - 92, 26.12.2018

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.  

References

  • 1. Burris 3rd H, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. Journal of clinical oncology. 1997;15(6):2403-13.
  • 2. Debiec-Rychter M, Cools J, Dumez H, Sciot R, Stul M, Mentens N, et al. Mechanisms of resistance to imatinib mesylate in gastrointestinal stromal tumors and activity of the PKC412 inhibitor against imatinib-resistant mutants. Gastroenterology. 2005;128(2):270-9.
  • 3. Manning G, Whyte DB, Martinez R, Hunter T, Sudarsanam S. The protein kinase complement of the human genome. Science. 2002;298(5600):1912-34.
  • 4. Escudier B, Szczylik C, Eisen T, Stadler W, Schwartz B, Shan M, et al. Randomized phase III trial of the Raf kinase and VEGFR inhibitor sorafenib (BAY 43–9006) in patients with advanced renal cell carcinoma (RCC). Journal of Clinical Oncology. 2005;23(16_suppl):LBA4510-LBA.
  • 5. Wilhelm S, Carter C, Lynch M, Lowinger T, Dumas J, Smith RA, et al. Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nature reviews Drug discovery. 2006;5(10):835.
  • 6. Connock M, Round J, Bayliss S, Tubeuf S, Greenheld W, Moore D. Sorafenib for the treatment of advanced hepatocellular carcinoma. Health Technol Assess. 2010;14(Suppl 1):17-21.
  • 7. Curtit E, Thiery-Vuillemin A, Nguyen T, Heyd B, Pivot X, Di Martino V, et al. Complete histologic response induced by sorafenib in advanced hepatocellular carcinoma: a case report. Journal of Clinical Oncology. 2011;29(12):e330-e2.
  • 8. Awada A, Hendlisz A, Gill T, Munoz R, Bartholomeus S, de Valeriola D, et al., editors. Final results of a clinical and pharmacokinetic (PK) phase I study of the Raf kinase inhibitor BAY 43-9006 in refractory solid cancers: a promising anti-tumor agent. EUROPEAN JOURNAL OF CANCER; 2002: PERGAMON-ELSEVIER SCIENCE LTD THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND.
  • 9. Clark JW, Eder JP, Ryan D, Lathia C, Lenz H-J. Safety and pharmacokinetics of the dual action Raf kinase and vascular endothelial growth factor receptor inhibitor, BAY 43-9006, in patients with advanced, refractory solid tumors. Clinical Cancer Research. 2005;11(15):5472-80.
  • 10. Moore M, Hirte H, Siu L, Oza A, Hotte S, Petrenciuc O, et al. Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Annals of oncology. 2005;16(10):1688-94.
  • 11. Zhao M, Rudek MA, He P, Hafner F-T, Radtke M, Wright JJ, et al. A rapid and sensitive method for determination of sorafenib in human plasma using a liquid chromatography/tandem mass spectrometry assay. Journal of Chromatography B. 2007;846(1-2):1-7.
  • 12. Jain L, Gardner ER, Venitz J, Dahut W, Figg WD. Development of a rapid and sensitive LC–MS/MS assay for the determination of sorafenib in human plasma. Journal of pharmaceutical and biomedical analysis. 2008;46(2):362-7.
  • 13. Kalaichelvi R, Jayachandren E. UV spectrophotometric estimation of sorafenib in pure and tablet dosage form. Journal of pharmacy research. 2011;4(10):3705-6.
  • 14. Shimada M, Okawa H, Maejima T, Yanagi T, Hisamichi K, Matsuura M, et al. A quantitative HPLC-UV method for determination of serum sorafenib and sorafenib N-oxide and its application in hepatocarcinoma patients. The Tohoku journal of experimental medicine. 2014;233(2):103-12.
There are 14 citations in total.

Details

Primary Language English
Subjects Health Care Administration
Journal Section Articles
Authors

Onur Şenol 0000-0002-0252-396X

Publication Date December 26, 2018
Submission Date July 17, 2018
Published in Issue Year 2018 Volume: 7 Issue: 3

Cite

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.

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