A Rapid and Simple TLC-Densitometric Method for Assay of Clobetasol Propionate in Topical Solution

Molecules

Maciej Thomas¹  Malgorzata Dolowy²  Alina Pyka-Pajak²  Josef Jampilek³  Violetta Kozik⁴  Andrzej Bak⁴  Krzysztof Barbusinski⁵ 

[1] Chemiqua Company, Skawinska 25/1, 31-066 Krakow, Poland;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;Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Comenius University, Odbojarov 10, 832 32 Bratislava, Slovakia;Institute of Chemistry, University of Silesia, Szkolna 9, 40-006 Katowice, Poland;Institute of Water and Wastewater Engineering, Silesian University of Technology, Konarskiego 18, 44-100 Gliwice, Poland;

关键词: clobetasol;    clobetasol propionate;    topical steroids;    TLC-densitometry;    validation;   

DOI  :  10.3390/molecules22111888

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown