Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors
- Авторы: Lar’kina M.1, Krivoshchekov S.1,2, Podrezova E.2, Bragina O.3, Chernov V.3, Nesterov E.2, Bodenko V.1, Belousov M.1, Yusubov M.1,2
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Учреждения:
- Siberian State Medical University
- National Research Tomsk Polytechnic University
- Cancer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
- Выпуск: Том 53, № 9 (2019)
- Страницы: 865-870
- Раздел: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/246038
- DOI: https://doi.org/10.1007/s11094-019-02091-z
- ID: 246038
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Аннотация
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.
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Об авторах
M. Lar’kina
Siberian State Medical University
Автор, ответственный за переписку.
Email: marialarkina@mail.ru
Россия, 2 Moskovskii Trakt St., Tomsk, 634050
S. Krivoshchekov
Siberian State Medical University; National Research Tomsk Polytechnic University
Email: marialarkina@mail.ru
Россия, 2 Moskovskii Trakt St., Tomsk, 634050; 30 Prosp. Lenina, Tomsk, 634050
E. Podrezova
National Research Tomsk Polytechnic University
Email: marialarkina@mail.ru
Россия, 30 Prosp. Lenina, Tomsk, 634050
O. Bragina
Cancer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Email: marialarkina@mail.ru
Россия, 5 Kooperativnyi Per., Tomsk, 634009
V. Chernov
Cancer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Email: marialarkina@mail.ru
Россия, 5 Kooperativnyi Per., Tomsk, 634009
E. Nesterov
National Research Tomsk Polytechnic University
Email: marialarkina@mail.ru
Россия, 30 Prosp. Lenina, Tomsk, 634050
V. Bodenko
Siberian State Medical University
Email: marialarkina@mail.ru
Россия, 2 Moskovskii Trakt St., Tomsk, 634050
M. Belousov
Siberian State Medical University
Email: marialarkina@mail.ru
Россия, 2 Moskovskii Trakt St., Tomsk, 634050
M. Yusubov
Siberian State Medical University; National Research Tomsk Polytechnic University
Email: marialarkina@mail.ru
Россия, 2 Moskovskii Trakt St., Tomsk, 634050; 30 Prosp. Lenina, Tomsk, 634050