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)

被引：0
|
作者：
Dudenkova, M. E. [1 ]
Grushevskaya, L. N. [1 ]
Sergeeva, M. S. [1 ]
Gaevaya, L. M. [1 ]
Denisenko, E. D. [1 ]
Minaev, S. V. [1 ]
Sazonova, N. M. [1 ]
机构：
[1] Russian Acad Sci, VV Zakusov State Inst Pharmacol, Moscow, Russia
来源：
PHARMACEUTICAL CHEMISTRY JOURNAL | 2020年 / 54卷 / 02期
关键词：
GK-2; residual organic solvents; gas chromatography; headspace extraction; validation;
D O I：
10.1007/s11094-020-02177-z
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
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, CH2Cl2 , Py, EtOH, Et2O, and trifluoroacetic acid. Validation of the method confirmed its specificity, linearity, accuracy, and precision.
引用
收藏
页码：195 / 200
页数：6
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