Reverse phase HPLC determination of sunitinib malate using UV detector, its isomerisation study, method development and validation
- Autores: Padervand M.1,2, Ghaffari S.1,3,4,5, Attar H.1,6, Nejad M.3
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Afiliações:
- Research and Development Department, Quality Control Laboratory
- Faculty of Science, Department of Chemistry
- Instrumental Analysis Department, Quality Control Laboratory
- Young Researchers and Elite Club, Pharmaceutical Sciences Branch
- Pharmaceutical Sciences Research Center, Pharmaceutical Sciences Branch
- Chemical Engineering Department, Engineering and Technology Faculty, Sciences and Research Branch
- Edição: Volume 72, Nº 5 (2017)
- Páginas: 567-574
- Seção: Articles
- URL: https://journals.rcsi.science/1061-9348/article/view/182461
- DOI: https://doi.org/10.1134/S1061934817050082
- ID: 182461
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Resumo
Sunitinib malate, as an anticancer compound and a multi-targeted tyrosine-kinase inhibitor for treatment of glioma, was comprehensively studied by using different liquid chromatography methods. Since sunitinib malate shows Z-E isomerism, various reverse phase high performance liquid chromatography (RP-HPLC) programs were designed to access quantitative determination and good separation of Z-E stereoisomers. Moreover, some impurities including N-oxide and impurity B were to be separated from the main isomer with acceptable resolution. In the present work, different RP-HPLC programs were developed in which the type of mobile phase, flow rate, pH, and temperature were optimized to reach the best analysis conditions and control the rate of Z to E conversion. In addition, the effect of some operational parameters during the solution preparation including initial concentration of the analyte, temperature, pH, and type of solvent on the stability of Z isomer were investigated. The opted conditions for quantitative analysis were C8-Hector column as stationary phase, methanol as solvent, ammonium acetate buffer containing triethylamine as mobile phase, the pH of mobile phase of 8.5, the flow rate of 1.0 mL/min, and detection at 425 nm. In this situation the peaks of E and Z isomers were at 16.3 and 19.7 min. Full validation of the designed method was done based on ICH guidelines.
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Sobre autores
Mohsen Padervand
Research and Development Department, Quality Control Laboratory; Faculty of Science, Department of Chemistry
Autor responsável pela correspondência
Email: mohsenpadervand@gmail.com
Irã, Tehran; Tehran
Solmaz Ghaffari
Research and Development Department, Quality Control Laboratory; Instrumental Analysis Department, Quality Control Laboratory; Young Researchers and Elite Club, Pharmaceutical Sciences Branch; Pharmaceutical Sciences Research Center, Pharmaceutical Sciences Branch
Email: mohsenpadervand@gmail.com
Irã, Tehran; Tehran; Tehran; Tehran
Hossein Attar
Research and Development Department, Quality Control Laboratory; Chemical Engineering Department, Engineering and Technology Faculty, Sciences and Research Branch
Email: mohsenpadervand@gmail.com
Irã, Tehran; Tehran
Mahdieh Nejad
Instrumental Analysis Department, Quality Control Laboratory
Email: mohsenpadervand@gmail.com
Irã, Tehran