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

M. S. Lar’kina, S. V. Krivoshchekov, E. V. Podrezova, O. D. Bragina, V. I. Chernov, E. A. Nesterov, V. V. Bodenko, M. V. Belousov, M. S. Yusubov

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)865-870
Number of pages6
JournalPharmaceutical Chemistry Journal
Volume53
Issue number9
DOIs
Publication statusPublished - 1 Dec 2019

Fingerprint

Octreotide
Neuroendocrine Tumors
High Pressure Liquid Chromatography
Radiopharmaceuticals
Phenylalanine
Amides
Quality Control
Amines
Limit of Detection

Keywords

  • chelate
  • HPLC
  • octreotide derivative
  • technetium-99m
  • validation

ASJC Scopus subject areas

  • Pharmacology
  • Drug Discovery

Cite this

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 journalArticle

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