Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors
| Autor: | S. V. Krivoshchekov, Mekhman S. Yusubov, V. V. Bodenko, O. D. Bragina, M. S. Lar’kina, M. V. Belousov, V. I. Chernov, Ekaterina V. Podrezova, E. A. Nesterov |
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| Rok vydání: | 2019 |
| Předmět: |
Pharmacology
Detection limit Chromatography Intralaboratory 010405 organic chemistry Chemistry business.industry Analytical hplc Octreotide Neuroendocrine tumors medicine.disease 01 natural sciences High-performance liquid chromatography 0104 chemical sciences 010404 medicinal & biomolecular chemistry chemistry.chemical_compound Drug Discovery medicine business Quality assurance Derivative (chemistry) medicine.drug |
| Zdroj: | Pharmaceutical Chemistry Journal. 53:865-870 |
| ISSN: | 1573-9031 0091-150X |
| Popis: | Preclinical studies of a new octreotide derivative with a chelate (DPAH-octreotide) that binds 99mTc for radiological diagnosis of neuroendocrine tumors are currently in progress. A method for preparing DPAH-octreotide is based on forming an amide bond between the amine of D-phenylalanine and the bifunctional chelate succinimid-1-yl 6-[bis(pyridin-2-ylmethyl)amino]hexanoate. An HPLC method for determining the identity, impurities, and quantitative content is proposed for DPAH-octreotide quality assurance. The validation protocol established that the HPLC analytical method for determining DPAH-octreotide had quality parameters for specificity, detection limit, linearity, accuracy, precision, and intralaboratory precision that met requirements for analytical methods and could be used for quality control of the finished product during manufacturing of reagents for preparation of related radiopharmaceuticals. |
| Databáze: | OpenAIRE |
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