PHARMACEUTICAL ANALYSIS AND STANDARDIZATION OF GIMANTAN PARENTERAL DOSAGE FORM

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作   者：

M. S. Sergeeva;  L. N. Grushevskaya;  B. M. Pyatin;  N. I. Avdyunina;  L. M. Gaevaya;  V. S. Klumova;  M. E. Dudenkova;  K. V. Alekseev;  E. A. Litvin; 

作者机构：

Moscow;  Russia.;  Zakusov State Institute of Pharmacology;  Russian Academy of Medical Sciences; 

关键词：

parenteral dosage form;  standardization;  gimantan;  gas chromatography.;  thin-layer chromatography;  pharmaceutical analysis; 

期刊名称：

Pharmaceutical Chemistry Journal

i s s n：

0091-150X

年卷期：

2011 年 45 卷 8 期

页   码：

499-502

页   码：

摘   要：

The objective of this investigation was to develop methods for the pharmaceutical analysis of a parenteral dosage form of gimantan, a new anti-Parkinson's drug. The physicochemical properties of gimantan solution for injection have been investigated. Methods for the determination of the impurity content and the quantitative drug assay were developed based on thin-layer chromatography (TLC) and gas chromatography (GC), respectively. The drug was identified using TLC and GC simultaneously with the purity evaluation and quantitative determination of gimantan. The stability during storage has been studied. The quality standards for gimantan parenteral dosage form have been developed.