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Title: Rapid and simple TLC-densitometric method for assay of clobetasol propionate in topical solution
Authors: Dołowy, Małgorzata
Kozik, Violetta
Bąk, Andrzej
Jampilek, Josef
Barbusiński, Krzysztof
Thomas, Maciej
Pyka-Pająk, Alina
Keywords: clobetasol; clobetasol propionate; topical steroids; TLC-densitometry; validation
Issue Date: 2017
Citation: EPJ Web of Conferences, Vol. 22, iss. 11 (2017), art. no 1888
Abstract: 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 g/spot. The limit of detection (LOD) and limit of quantification (LOQ) value is 0.061 and 0.186 g/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.
DOI: 10.3390/molecules22111888
ISSN: 1420-3049
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