Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Federal State Budgetary Institution, 8/2 Petrovsky Blvd, Moscow 127051, Russian Federation.
J Chromatogr Sci. 2024 Aug 20;62(7):601-610. doi: 10.1093/chromsci/bmad086.
A simple, fast, precision and sensitive gas chromatographic method was developed for determination of camphor, L-menthol, methyl salicylate, salicylic acid, benzyl nicotinate and nonivamide in topical formulations. The possibility of determination low-boiling components and high-boiling components by a single analytical method was shown. The method was optimized by evaluating the effect of a large number of chromatographic parameters and sample preparation stages. It was validated according to the International Council on Harmonization guidelines. Limit of quantification of active components were achieved from 0.7 μg/mL for benzyl nicotinate and L-menthol to 41 μg/mL for salicylic acid. High repeatability and good recovery values were demonstrated. The practical application of the proposed method was shown for ointments and cream.
建立了一种简单、快速、准确、灵敏的气相色谱法，用于测定局部制剂中的樟脑、L-薄荷醇、水杨酸甲酯、水杨酸、烟碱酸苄酯和辣椒素。该方法显示了通过单一分析方法测定低沸点成分和高沸点成分的可能性。通过评估大量色谱参数和样品制备阶段的影响对方法进行了优化。该方法根据国际协调理事会的指导方针进行了验证。从烟碱酸苄酯和 L-薄荷醇的 0.7μg/mL 到水杨酸的 41μg/mL 实现了活性成分的定量限。结果表明该方法具有较高的重现性和良好的回收率。该方法还成功应用于软膏和乳膏制剂的分析。
