Affiliation:
1. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Cairo University, El-Kasr El- Ainy 11562, Cairo, Egypt
Abstract
Introduction:
(COPD) Chronic Obstructive Pulmonary Disease is a partially reversible and
treatable lung disease, characterized by progressive limitation of airflow. It is one of the main causes of
mortality and morbidity worldwide.
Methods:
An easy, precise and selective reversed-phase liquid chromatographic method, with stabilityindicating
assay was established and validated for the determination of indacaterol maleate and glycopyrronium
bromide in the mixture. In addition, a forced degradation study was performed for indacaterol
maleate, comprised of hydrolysis by acid and base, degradation by oxidation and heat, and
photo-degradation. Separation and forced degradation were done by isocratic elution using a reversed
phase phenyl column and (methanol: phosphate buffer) at ratio (65:35, v/v) with 3.5 pH buffer as an
eluent at 1 mL min-1 as a flow rate. Quantitation was accomplished using a UV detector at 210 nm.
Results:
The method showed good separation of glycopyrronium bromide, indacaterol maleate and its
degradation products. Accuracy, linearity, and precision were acceptable over 10-160 µg mL-1 and 10-
80 µg mL-1 concentration range for indacaterol maleate and glycopyrronium bromide, respectively.
Conclusion:
The proposed method does not require any previously done separation steps, making it
applicable for the analysis of the drugs under investigation in their pharmaceutically marketed preparations.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics
Cited by
3 articles.
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