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 | |
| Publication status | Published - 1 Dec 2019 |
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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 journal › Article
}
TY - JOUR
T1 - Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors
AU - Lar’kina, M. S.
AU - Krivoshchekov, S. V.
AU - Podrezova, E. V.
AU - Bragina, O. D.
AU - Chernov, V. I.
AU - Nesterov, E. A.
AU - Bodenko, V. V.
AU - Belousov, M. V.
AU - Yusubov, M. S.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - 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.
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.
KW - chelate
KW - HPLC
KW - octreotide derivative
KW - technetium-99m
KW - validation
UR - http://www.scopus.com/inward/record.url?scp=85076233082&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85076233082&partnerID=8YFLogxK
U2 - 10.1007/s11094-019-02091-z
DO - 10.1007/s11094-019-02091-z
M3 - Article
AN - SCOPUS:85076233082
VL - 53
SP - 865
EP - 870
JO - Pharmaceutical Chemistry Journal
JF - Pharmaceutical Chemistry Journal
SN - 0091-150X
IS - 9
ER -