Two validated liquid chromatographic methods for the simultaneous determination of flumethasone pivalate, its related substance (flumethasone), and clioquinol

Abstract

Two liquid chromatographic methods were developed and validated. Simple and sensitive thin-layer chromatography (TLC)-densitometric and high-performance liquid chromatographic (HPLC) methods were used for the simultaneous determination of flumethasone pivalate (FP), flumethasone pivalate related substance and impurity, flumethasone (FL), and clioquinol (CL). The proposed TLC-densitometric method has been developed using silica gel plates 60 F254 as a stationary phase with benzene-hexane-acetone-formic acid (5:4:2:0.13, by volume) as a developing system followed by densitometric measurements at 235 nm. The studied components were quantified in the range of 0.3–4, 0.3–3, and 1.5–5 μg band−1, respectively. For HPLC method, chromatographic separation was achieved within 11 min with the required peak symmetry, accuracy, and precision on ODS column using acetonitrile-water (70:30, v/v) as the mobile phase at a flow rate of 1 mL min−1 with ultraviolet (UV) detection at 235 nm. The calibration plots were linear o...