Reverse phase HPLC determination of sunitinib malate using UV detector, its isomerisation study, method development and validation
- Authors: Padervand M.1,2, Ghaffari S.1,3,4,5, Attar H.1,6, Nejad M.M.3
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Affiliations:
- 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
- Issue: Vol 72, No 5 (2017)
- Pages: 567-574
- Section: Articles
- URL: https://journals.rcsi.science/1061-9348/article/view/182461
- DOI: https://doi.org/10.1134/S1061934817050082
- ID: 182461
Cite item
Abstract
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.
Keywords
About the authors
Mohsen Padervand
Research and Development Department, Quality Control Laboratory; Faculty of Science, Department of Chemistry
Author for correspondence.
Email: mohsenpadervand@gmail.com
Iran, Islamic Republic of, 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
Iran, Islamic Republic of, 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
Iran, Islamic Republic of, Tehran; Tehran
Mahdieh Mohammad Nejad
Instrumental Analysis Department, Quality Control Laboratory
Email: mohsenpadervand@gmail.com
Iran, Islamic Republic of, Tehran