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

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.

Simple and Accurate HPTLC-Densitometric Method for Assay of Nandrolone Decanoate in Pharmaceutical Formulation

“…UV-Vis detection was performed at λ = 240 nm [6]. Our previous studies and the papers prepared by other researchers confirm also the utility of thin-layer chromatography (TLC) for the purpose of separation and quantitative analysis of various steroids, including selected anabolic-androgenic agents [7,8,9,10,11,12,13,14,15,16,17], because of its simplicity, low cost, and relatively low detection limit compared to other more modern chromatographic methods, such HPLC with different detection systems. Importantly, it does not need any tedious cleanup of the sample.…”

“…In continuation of our previous studies on the development of a HPTLC-densitometric method for analysis of steroids in pharmaceutical formulations [7,8,9,10,11], this work describes a rapid and accurate procedure suitable for effective quantitative assay based on the conventional high performance thin-layer chromatographic method in combination with densitometry (HPTLC-densitometry) for quantitative determination of nandrolone decanoate in bulk drugs, as well as the commercially available injection formulation. The proposed method was validated according to the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) [18].…”

Analytical method development and validation for simultaneous determination of triamcinolone acetate, betamethasone valerate and clobetasol propionate in cream formulation by RP-HPLC

“…Various methods have been reported for the qualitative and quantitative determination of corticosteroids in creams or cosmetics. Some examples include qualitative or semiquantitative analysis by thin-layer chromatography (TLC) (Alam et al, 2015) and TLC with UV spectrophotometry (Bassuoni et al, 2016;Dolowy et al, 2017;Roychowdhury and Das, 1996). Although spectroscopic methods and TLC are simple and rapid, they have low sensitivity, accuracy, and specificity and might require sample pretreatment.…”