Development and Validation of a Method for Identification and Quantitative Determination of Residual Organic Solvents in the Drug Substance of a Dipeptide Mimetic of Nerve Growth Factor (Gk-2)

Anovel gas-chromatographic method with static headspace extraction was developed and validated for identifying and determining quantitatively residual organic solvents in the drug substance of an innovative dipeptide mimetic of nerve growth factor (GK-2). The developed chromatography conditions allo...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2020-05, Vol.54 (2), p.195-200
Main Authors: Dudenkova, M. E., Grushevskaya, L. N., Sergeeva, M. S., Gaevaya, L. M., Denisenko, E. D., Minaev, S. V., Sazonova, N. M.
Format: Article
Language:English
Subjects:
Analysis
Chromatography
Medicine
Methods
Nerve growth factor
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
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Summary:Anovel gas-chromatographic method with static headspace extraction was developed and validated for identifying and determining quantitatively residual organic solvents in the drug substance of an innovative dipeptide mimetic of nerve growth factor (GK-2). The developed chromatography conditions allowed effective separation of the chromatographic peaks for all organic solvents used to synthesize and purify the drug substance, i.e., MeOH, toluene, CH 2 Cl 2 , Py, EtOH, Et 2 O, and trifluoroacetic acid. Validation of the method confirmed its specificity, linearity, accuracy, and precision.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-020-02177-z