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

Abstract

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.

Original language	English
Pages (from-to)	865-870
Number of pages	6
Journal	Pharmaceutical Chemistry Journal
Volume	53
Issue number	9
DOIs	https://doi.org/10.1007/s11094-019-02091-z
Publication status	Published - 1 Dec 2019

Keywords

chelate
HPLC
octreotide derivative
technetium-99m
validation

ASJC Scopus subject areas

Pharmacology
Drug Discovery

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Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors. / Lar’kina, M. S.; Krivoshchekov, S. V.; Podrezova, E. V.; Bragina, O. D.; Chernov, V. I.; Nesterov, E. A.; Bodenko, V. V.; Belousov, M. V.; Yusubov, M. S.

In: Pharmaceutical Chemistry Journal, Vol. 53, No. 9, 01.12.2019, p. 865-870.

Research output: Contribution to journal › Article › peer-review

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abstract = "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.",

keywords = "chelate, HPLC, octreotide derivative, technetium-99m, validation",

author = "Lar{\textquoteright}kina, {M. S.} and Krivoshchekov, {S. V.} and Podrezova, {E. V.} and Bragina, {O. D.} and Chernov, {V. I.} and Nesterov, {E. A.} and Bodenko, {V. V.} and Belousov, {M. V.} and Yusubov, {M. S.}",

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AU - Bragina, O. D.

AU - Chernov, V. I.

AU - Nesterov, E. A.

AU - Bodenko, V. V.

AU - Belousov, M. V.

AU - Yusubov, M. S.

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AB - 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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