Abstract
APPLICATION OF TLC DENSITOMETRIC AND UV SPECTROPHOTOMETRIC TECHNIQUES FOR SIMULTANEOUS DETERMINATION OF INDACATEROL AND GLYCOPYRRONIUM IN INHALATION CAPSULES USED FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Nasr Mohamed A. El-Abasawy, Khalid Abdel-Salam M. Attia, Ahmed A. Abouserie, Ahmed El-Olemy, Ayman Osman Elsayed*

ABSTRACT

Indacaterol and glycopyrronium are co-formulated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). In the present work; first reported, accurate, precise TLC densitometric method and UV spectrophotometric methods developed for simultaneous determination of indacaterol and glycopyrronium in their bulk and dosage form. The proposed TLC densitometric method based on determination of the UV-visualized bands after TLC separation of indacaterol and glycopyrronium using 60 F254 silica gel plates and mobile phase consists of (60% Methanol:30%ethylacetate:10%water by volume) with UV detection at 260 nm. The relationship between the concentration of standard solutions and the peak response is linear within the concentration range of 1-6 μg/spot for indacaterol and 0.5-3 μg/spot for glycopyrronium. Alternatively the UV spectrophotometric methods based on determination of indacaterol in presence of glycopyrronium using zero order spectrophotometric method also determination of glycopyrronium in presence of indacaterol through manipulation of the ratio spectra by three methods namely; ratio difference, ratio derivative and mean centering. The proposed techniques have been validated according to ICH guidelines and show high sensitivity, accuracy and precision and the results were statistically compared to reported method.

Keywords: Indacaterol, Glycopyrronium, TLC-Densitometry, UV-spectrophotometric methods, Ultibro®.


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