Abstract
A stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of Formoterol fumarate (FOR), Tiotropium bromide (TRI), and Ciclesonide (CLS) in a pulmonary drug product. The desired chromatographic separation was achieved on the Zorbax SB C8, 5 μm (150 × 4.6 mm) column, using gradient elution at 230 nm detector wavelength. The optimized mobile phase consisted of a 0.2 % v/v perchloric acid as solvent-A and acetonitrile as solvent-B. The developed method separated FOR, TRI, and CLS in the presence of its five unknown degradation products within 10 minutes. The stability-indicating capability was established by forced degradation experiments and the separation of unknown degradation products. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method was applied for the simultaneous estimation of FOR, TRI, and CLS in commercially available Triohale® pMDI (Pressurized Metered-Dose Inhaler) samples. Furthermore, this method can be extended for individual estimation of FOR, TRI, and CLS in various commercially available pulmonary dosage forms.
Highlights
The combination inhaler drug combines three essential medicines that are recommended for use in patients with severe Chronic Obstructive Pulmonary Disease (COPD)
A rapid, reversed-phase high performance liquid chromatography (RP-HPLC) method was successfully developed for the simultaneous estimation of FOR, Tiotropium bromide (TRI), and CLS in a pressurized metered-dose inhaler
Forced degradation data proved that the method is specific for the analytes and free from the interference of placebo and unknown degradation products
Summary
The combination inhaler drug combines three essential medicines that are recommended for use in patients with severe Chronic Obstructive Pulmonary Disease (COPD). It contains a long-acting anticholinergic (Tiotropium), a long-acting beta-2-agonist (Formoterol), and an inhalable corticosteroid (Ciclesonide). Patients suffering from COPD who were prescribed combination inhaler drug product (Triohale®) will have to take just two puffs a day. This is a significant improvement over the current therapy involving two to three inhalers which can be confusing for some patients. There is no cure for COPD, the use of combination inhaler drug product will reduce symptoms, increase lung function, decrease the number of times patients are hospitalized, and lead to improved quality of life [1]
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