Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors

Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors

Bibliographic Details
Parent link:Pharmaceutical Chemistry Journal
Vol. 53, iss. 9.— 2019.— [P. 865-870]
Other Authors: Larkina M. S. Mariya Sergeevna, Krivoshchekov S. V. Sergey Vladimirovich, Podrezova E. V. Ekaterina Vladimirovna, Bragina O. D. Olga Dmitrievna, Chernov V. I. Vladimir Ivanovich, Nesterov E. A. Evgeny Alexandrovich, Bodenko V. V. Vitalina Vasiljevna, Belousov M. V. Mikhail Valerievich, Yusubov M. S. Mekhman Suleiman-Ogly (Suleimanovich)
Summary:Title screen
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 validationprotocol 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.
Режим доступа: по договору с организацией-держателем ресурса
Published: 2019
Subjects:
электронный ресурс
труды учёных ТПУ
octreotide derivative
chelate
technetium-99m
HPLC
validation
хелаты
технеций
технеций-99м
Online Access:https://doi.org/10.1007/s11094-019-02091-z
Format: Electronic Book Chapter
KOHA link:https://koha.lib.tpu.ru/cgi-bin/koha/opac-detail.pl?biblionumber=662001

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