Abstract
Two simple, accurate, and selective spectrophotometric methods were developed to determine aclidinium in the presence of formoterol as interferent compound in Duaklir Genuair inhalation powder. The methods under study are ratio derivative and ratio subtraction spectrophotometric methods. These methods are based on different mathematical processing of the obtained ratio spectra. The methods are linear over the concentration range of 5–50 µg/mL for aclidinium and validated according to the ICH guidelines. The accuracy and precision are found to be within the acceptable limits and assessed by applying the standard addition technique. The specificity of the proposed methods was tested using laboratory-prepared mixtures. Furthermore, the methods were statistically compared to the reported RP-HPLC method, and good results were obtained.
Highlights
Duaklir Genuair is a recently approved two-component inhalation mixture of aclidinium and formoterol used to relieve symptoms in adult patients with chronic obstructive pulmonary disease [1]
Aclidinium bromide and formoterol fumarate dihydrate are the active ingredients of Duaklir Genuair inhalation powder
The main theme of this work is to determine aclidinium bromide in the presence of formoterol fumarate dihydrate as the interferent using two methods manipulate ratio spectra, namely, ratio derivative and ratio subtraction. e ratio spectra were obtained by dividing aclidinium spectra by a definite concentration of formoterol
Summary
Duaklir Genuair is a recently approved two-component inhalation mixture of aclidinium and formoterol used to relieve symptoms in adult patients with chronic obstructive pulmonary disease [1]. Aclidinium (Figure 1(a)) acts through its binding to M3 receptors located on the bronchial smooth muscle and the vascular endothelium in the lung resulting in bronchodilation [2, 3]. Formoterol (Figure 1(b)) exhibits its bronchodilator activity through its long and selective sympathomimetic action on the bronchial smooth muscles [4]. The aim of the present work is to develop two accurate and precise spectrophotometric methods manipulating ratio spectra, namely, ratio derivative [18] and ratio subtraction [19, 20]. E methods were applied for the determination of aclidinium in the presence of formoterol as the interferent compound in Duaklir Genuair and in their laboratoryprepared mixtures.
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