Development and Validation of a Method for Assay of Residual Organic Solvents in Kemantane Substance by Gas Liquid Chromatography

被引：1

作者：

Tolkacheva, A. V. ^{[1
,2
]}

Grushevskaya, L. N. ^{[1
]}

Avdyunina, N. I. ^{[1
]}

Pyatin, B. M. ^{[1
]}

Prokof'eva, V. I. ^{[2
]}

Gaevaya, L. M. ^{[1
]}

Zaitseva, N. M. ^{[1
]}

机构：

[1] VV Zakusov Sci Res Inst Pharmacol, Moscow 125315, Russia

[2] IM Sechenov First Moscow Med Univ, Moscow 119991, Russia

来源：

PHARMACEUTICAL CHEMISTRY JOURNAL | 2015年 / 49卷 / 01期

关键词：

kemantane; 5-hydroxyadamantan-2-one; pharmaceutical substance; residual organic solvents; vapor phase extraction (headspace method); validation; gas liquid chromatography; GLC;

D O I：

10.1007/s11094-015-1222-z

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

The aim of the present work was to develop and validate an assay for residual organic solvents in kemantane substance (5-hydroxyadamantan-2-one) by gas liquid chromatography (GLC-FID). Experiments were performed using a gas chromatograph with a flame ionization detector and an autosampler. Chromatographic separation was performed on a VF-624ms quartz capillary column of length 60 m and diameter 0.32 mm, with an applied immobile phase 1.80 mu m thick. Volatile organic solvent extraction was improved by vapor phase extraction (headspace method). The method was validated in terms of its main characteristics. Parameters for the suitability of the chromatography system were developed. Batch samples of kemantane substance were analyzed.

引用

页码：59 / 64

页数：6

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