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

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.

Язык оригинала	Английский
Страницы (с-по)	865-870
Число страниц	6
Журнал	Pharmaceutical Chemistry Journal
Том	53
Номер выпуска	9
DOI	https://doi.org/10.1007/s11094-019-02091-z
Состояние	Опубликовано - 1 дек 2019

ASJC Scopus subject areas

Pharmacology
Drug Discovery

Доступ к документу

10.1007/s11094-019-02091-z

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Цитировать

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. (2019). Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors. Pharmaceutical Chemistry Journal, 53(9), 865-870. https://doi.org/10.1007/s11094-019-02091-z

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.

В: Pharmaceutical Chemistry Journal, Том 53, № 9, 01.12.2019, стр. 865-870.

Результат исследований: Материалы для журнала › Статья

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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.",

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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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