CAMAG AG, Sonnenmattstrasse 11, 4132 Muttenz, Switzerland.
Extrasynthese, Impasse Jacquard, F-69730 Genay, France.
Pharmeur Bio Sci Notes. 2021;2021:157-166.
The European Pharmacopoeia (Ph. Eur.), includes both individual monographs on essential oils and a general monograph that covers all essential oils for pharmaceutical use, whether covered by an individual monograph or not. The individual monographs generally describe gas chromatography as a first identification test, while thin-layer chromatography (TLC) and high-performance thin-layer chromatography (HPTLC) methods are included in the second identification series. To comply with Ph. Eur. general chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations, HPTLC parameters must be standardised. Currently, 18 of the 32 monographs on essential oils feature the same TLC/HPTLC method, but differ in terms of the other conditions described. A single, standardised chromatographic system with a system suitability test (SST) and intensity markers for all 32 essential oils covered by individual monographs would be desirable, particularly for pharmacies and other users that cannot perform gas chromatography for financial reasons. To this end, this paper describes the development of a general HPTLC method for the identification of essential oils in compliance with general chapter 2.8.25. The method proposes the use of ethyl acetate, toluene (5:95 V/V) as mobile phase, isoeugenol/isoeugenyl acetate for the SST, and a combination of one alcohol (either borneol or linalool) and one ester (either linalyl acetate or bornyl acetate) as intensity markers.
《欧洲药典》（Ph. Eur.）包含关于精油的个别专论以及涵盖所有用于制药的精油的一般专论，无论是否有个别专论涵盖。个别专论通常将气相色谱法描述为第一鉴定测试，而薄层色谱法（TLC）和高效薄层色谱法（HPTLC）方法包含在第二鉴定系列中。为了符合《欧洲药典》通则 2.8.25，草药药物和草药制剂的高效薄层色谱法的 HPTLC 参数必须标准化。目前，32 种精油专论中有 18 种采用相同的 TLC/HPTLC 方法，但其他描述条件不同。对于因财务原因无法进行气相色谱法的药店和其他用户来说，需要一个单一的、标准化的色谱系统，带有系统适用性测试（SST）和所有 32 种精油的强度标记，这将是理想的。为此，本文描述了一种符合通则 2.8.25 的通用 HPTLC 方法的开发，用于鉴定精油。该方法建议使用乙酸乙酯、甲苯（5:95 V/V）作为流动相，异丁香酚/异丁香酚乙酸酯作为 SST，以及醇（龙脑或芳樟醇）和酯（乙酸龙脑酯或乙酸柏木酯）的组合作为强度标记。
