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

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

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 μm 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.

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Correspondence to A. V. Tolkacheva.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 49, No. 1, pp. 42 – 47, January, 2015.

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Tolkacheva, A.V., Grushevskaya, L.N., Avdyunina, N.I. et al. Development and Validation of a Method for Assay of Residual Organic Solvents in Kemantane Substance by Gas Liquid Chromatography. Pharm Chem J 49, 59–64 (2015). https://doi.org/10.1007/s11094-015-1222-z

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  • DOI: https://doi.org/10.1007/s11094-015-1222-z

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