Abstract
Objective: The objective of the present work was to develop validated stability-indicating high-performance thin-layer chromatographic method for simultaneous estimation of formoterol fumarate dihydrate (FFD) and fluticasone propionate (FP) in bulk drug and pharmaceutical dosage form.
 Methods: Pre-coated silica gel aluminum plates 60 F-254 were used as stationary phase. The mixture of toluene:ethyl acetate:formic acid (98%) (6:4:0.1; v/v/v) was used as a mobile phase. The densitometric quantification was carried out at 233 nm. The method was validated according to the ICH guidelines. The specificity and stability indicating the capability of the method were proven though degradation studies. Both drugs were subjected to acid (0.1N HCl) and base (0.1N NaOH) hydrolysis, oxidation (3% v/v H2O2), photolytic, and neutral degradation conditions.
 Results: The selected mobile phase resolved peaks of FFD and FP with Rf values 0.27±0.10 and 0.64±0.10, respectively. Determination coefficients of calibration curves were found to be 0.998 and 0.999 in the range of 1–3.5 μg/spot and 10–60 μg/spot for FFD and FP with an accuracy of 99.09% for FFD and 99.20% for FP. The degradation products of FFD and FP were resolved from the pure drug with significant differences in their retention factor values.
 Conclusion: The developed method is simple, accurate and can be successfully applied for quantification of FFD and FP in bulk drug and pharmaceutical dosage form, contributing to improve the quality control and assure the therapeutic efficacy.
Highlights
Inhalation is currently the preferred route of drug delivery in asthma in accordance with a global initiative for asthma guideline [1], as it allows the release of drug directly to the site where the action is needed, minimizing systemic side effect
Formoterol fumarate dihydrate (FFD) is a longacting selective β-2 agonist used as a bronchodilator in the treatment of asthma
The chemical structures of FFD and Fluticasone propionate (FP) [8] are shown in Fig. 1a and b, respectively
Summary
Inhalation is currently the preferred route of drug delivery in asthma in accordance with a global initiative for asthma guideline [1], as it allows the release of drug directly to the site where the action is needed, minimizing systemic side effect. Inhaled corticosteroid in combination with a long-acting β2-agonist is the gold standard for the management of persistent asthma, with maximal local targeting and minimal systemic side effects. Formoterol fumarate dihydrate (FFD) is a longacting selective β-2 agonist used as a bronchodilator in the treatment of asthma. FFD is a (E)-but-2-enedioic acid; N-[2-hydroxy5-[(1S)-1-hydroxy-2-[[(2S)-1-(4-methoxyphenyl) propan-2-yl] amino] ethyl] phenyl]formamide [2,3]. FP is a tri-fluorinated glucocorticoid designed to provide enhanced antiinflammatory effect [2,4]. Both drugs are official in IP, BP, EP, and USP [5,6,7,8]. The chemical structures of FFD and FP [8] are shown in Fig. 1a and b, respectively
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