Development and Validation of a Stability-Indicating Chromatographic Method for the Determination of Indacaterol Maleate with Glycopyrronium Bromide in Mixture

Author(s): Sonia Talaat Hassib, Hanaa Abdelmenem Hashem, Marwa Ahmed Fouad*, Nehal Essam Eldin Mohamed.

Journal Name: Current Pharmaceutical Analysis

Volume 15 , Issue 7 , 2019

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Graphical Abstract:


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.

Keywords: Indacaterol maleate, glycopyrronium bromide, HPLC, forced degradation, chronic, pulmonary.

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Article Details

VOLUME: 15
ISSUE: 7
Year: 2019
Page: [694 - 702]
Pages: 9
DOI: 10.2174/1573412914666180608095420
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