A rapid and simple TLC-Densitometric method for assay of cobetasol propionate in topical solution
Authors:
- Małgorzata Dolowy,
- Violetta Kozik,
- Andrzej Bąk,
- Josef Jampilek,
- Krzysztof Barbusinki,
- Maciej Thomas,
- Alina Pyka-Pająk
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 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.
- Record ID
- CUTc2449ffc878f400c833c48cc5737d8bd
- Publication categories
- ;
- Author
- Journal series
- Molecules, ISSN , e-ISSN 1420-3049, Biweekly
- Issue year
- 2017
- Vol
- 22
- No
- 11
- Pages
- [1-13]
- Article number
- 1888
- Other elements of collation
- tab.; wykr.; Bibliografia (na s.) - 12-13; Bibliografia (liczba pozycji) - 29; Oznaczenie streszczenia - Abstr.; Numeracja w czasopiśmie - Vol. 22, Iss. 11, Spec. Iss.
- Substantive notes
- Special Issue: Selected Papers from the 46th EuroCongress on Drug Synthesis and Analysis (ECDSA-2017)
- Keywords in English
- clobetasol, clobetasol propionate, topical steroids, TLC-densitometry, validation
- DOI
- DOI:10.3390/molecules22111888 Opening in a new tab
- URL
- https://www.mdpi.com/1420-3049/22/11/1888 Opening in a new tab
- Language
- eng (en) English
- License
- Score (nominal)
- 0
- Publication indicators
- Additional fields
- Indeksowana w: Web of Science, Scopus
- Uniform Resource Identifier
- https://cris.pk.edu.pl/info/article/CUTc2449ffc878f400c833c48cc5737d8bd/
- URN
urn:pkr-prod:CUTc2449ffc878f400c833c48cc5737d8bd
* presented citation count is obtained through Internet information analysis, and it is close to the number calculated by the Publish or PerishOpening in a new tab system.