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

Результат исследований: Материалы для журналаСтатья

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 оригиналаАнглийский
Страницы (с-по)865-870
Число страниц6
ЖурналPharmaceutical Chemistry Journal
Том53
Номер выпуска9
DOI
СостояниеОпубликовано - 1 дек 2019

ASJC Scopus subject areas

  • Pharmacology
  • Drug Discovery

Fingerprint Подробные сведения о темах исследования «Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors». Вместе они формируют уникальный семантический отпечаток (fingerprint).

  • Цитировать