Development and Validation of a Fast RP-HPLC Method for the Determination of Clobetasol Propionate in Topical Nanocapsule Suspensions

• Published in: Journal of chromatographic science 2010-09, Vol.48 (8), p.637-640
• Main Authors: Fontana, M.C., Bastos, M.O., Beck, R.C.R.
• Format: Article
• Language: English
• Subjects: Administration, Topical; Analysis; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Chromatography, Reverse-Phase - methods; Clobetasol - analysis; Clobetasol - chemistry; General pharmacology; Linear Models; Medical sciences; Nanocapsules - chemistry; Pharmacology. Drug treatments; Reproducibility of Results; Sensitivity and Specificity
• ISSN: 0021-9665; 1945-239X
• DOI: 10.1093/chromsci/48.8.637

A simple and rapid high-performance liquid chromatographic method is validated for the determination of clobetasol propionate in topical nanocapsule suspensions. The method is carried out on an RP-18 column with a mobile phase composed of methanol-water (80:20 v/v) and UV detection at 241 nm. The method validation yields good results with respect to linearity, specificity, precision, accuracy, and robustness. The calibration curve in the range of 5.0–40.0 µg/mL shows a correlation coefficient of 0.9999. Precision (intra-day and inter-day) is demonstrated by a relative standard deviation lower than 1.5%. Accuracy is assessed by the recovery test of clobetasol propionate from sample matrixes (98.33 ± 0.88%). In conclusion, the method is suitable to be applied to assay clobetasol propionate in topical formulations of polymeric nanocapsules, avoiding the use of a buffer solution in the mobile phase.