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Abstract
BackgroundChronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. A combination of indacaterol maleate with glycopyrronium bromide has recently been approved as a once-daily maintenance therapy in patients with COPD. The very low dose (μg level/capsule) renders the analysis of such products challenges. This study reports for the first time about HPLC method for the quality control of such combination and it is a stability indicating at the same time.ResultsA rapid, simple, precise and reproducible HPLC method was developed and validated for simultaneous determination of indacaterol maleate and glycopyrronium bromide using tenoxicam as an internal standard. The chromatographic separation was achieved on an onyx monolithic C18 column (100 × 4.6 mm) using a mobile phase consisting of acetonitrile and 30 mM phosphate buffer (pH 3.5) (30:70, v/v), run at a flow rate of 2 mL/min with UV detection at 210 nm. The total analysis time was less than 3 min. The HPLC method was validated for linearity, limits of detection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in the concentration ranges of 1–44 µg/mL for indacaterol maleate and 0.5–20 µg/mL for glycopyrronium bromide. Stability tests were done through exposure of the analyte solution for different stress conditions and the results indicate no interference of degradants with HPLC method.ConclusionsThe method was successfully applied for the quantitative analysis of indacaterol maleate and glycopyrronium bromide both individually and in a combined pharmaceutical inhaler capsules to support the quality control and to assure the therapeutic efficacy of the two drugs. The simple procedure involved in sample preparation and the short run-time added the important property of high throughput to the method. Graphical abstractChemical structures and representative HPLC chromatogram of indacaterol maleate (IND; 22 μg/mL), glycopyrronium bromide (GLY; 10 μg/mL) and tenoxicam (IS, 15μg/mL) in commercial capsules.
Highlights
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide
Chronic obstructive pulmonary disease (COPD) is a prevalent lung disease caused by chronic airway and pulmonary inflammation which lead to progressive airflow limitation
The present study describes, for the first time, a rapid, simple and stability-indicating High-performance liquid chromatography (HPLC) method using a monolithic column with UV detection
Summary
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. The combination of IND and GLY as a dual-bronchodilator therapy is the preferred choice for COPD treatment because of its powerful bronchodilator effects and a simple once-daily inhalation regimen [4]. Few analytical methods have been reported in the literature for the individual determination of IND or GLY. These methods include: spectrophotometry [5, 6], HPLC [7], GC [8], spectrofluorometry [5] and HPLC–MS methods [9,10,11,12,13,14]. No HPLC method for simultaneous determination of IND and GLY in combined dosage forms has been reported so far
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