Department of Analytical Chemistry, School of Pharmacy with Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, Jagiellonska 4, 41-200 Sosnowiec, Poland.
Institute of Chemistry, University of Silesia, Szkolna 9, 40-006 Katowice, Poland.
Molecules. 2017 Nov 3;22(11):1888. doi: 10.3390/molecules22111888.
A rapid, simple to use and low-cost thin-layer chromatographic procedure in normal phase system with densitometric detection at 246 nm was carefully validated according to the International Conference on Harmonisation (ICH) guidelines for assay of clobetasol propionate in topical solution containing clobetasol propionate in quantity 0.50 mg/mL. The adopted thin-layer chromatographic (TLC)-densitometric procedure could effectively separate clobetasol propionate from its related compound, namely clobetasol. It is linear for clobetasol propionate in the range of 0.188 ÷ 5 µg/spot. The limit of detection (LOD) and limit of quantification (LOQ) value is 0.061 and 0.186 µg/spot, respectively. Accuracy of proposed procedure was evaluated by recovery test. The mean recovery of studied clobetasol propionate ranges from 98.7 to 101.0%. The coefficient of variation (CV, %) obtained during intra-day and inter-day studies, which was less than 2% (0.40 ÷ 1.17%), confirms the precision of described method. The assay value of clobetasol propionate is consistent with the pharmacopoeial requirements. In conclusion, it can be suitable as a simple and economic procedure for routine quality control laboratories of clobetasol propionate in topical solution.
根据国际协调会议（ICH）关于含 0.50 毫克/毫升丙酸氯倍他索的局部溶液中丙酸氯倍他索含量测定的指南，精心验证了一种快速、使用简便且成本低廉的正相体系中薄层色谱程序，并用 246nm 处的密度检测法进行检测。所采用的薄层色谱（TLC）-密度测定程序能够有效地将丙酸氯倍他索与其相关化合物（即氯倍他索）分离。该方法在 0.188÷5μg/斑点范围内对丙酸氯倍他索呈线性。检测限（LOD）和定量限（LOQ）值分别为 0.061 和 0.186μg/斑点。通过回收率试验评估了所提议程序的准确性。研究的丙酸氯倍他索的平均回收率范围为 98.7%至 101.0%。日内和日间研究期间获得的变异系数（CV，%）小于 2%（0.40÷1.17%），证实了该方法的精密度。丙酸氯倍他索的测定值符合药典要求。总之，它可以作为常规质量控制实验室中局部溶液中丙酸氯倍他索的简单经济程序。
