Background: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide.\nA combination of indacaterol maleate with glycopyrronium bromide has recently been approved as a once-daily\nmaintenance therapy in patients with COPD. The very low dose (Ã?¼g level/capsule) renders the analysis of such products\nchallenges. This study reports for the first time about HPLC method for the quality control of such combination\nand it is a stability indicating at the same time.\nResults: A rapid, simple, precise and reproducible HPLC method was developed and validated for simultaneous\ndetermination of indacaterol maleate and glycopyrronium bromide using tenoxicam as an internal standard. The\nchromatographic separation was achieved on an onyx monolithic C18 column (100 Ã?â?? 4.6 mm) using a mobile phase\nconsisting 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\ndetection at 210 nm. The total analysis time was less than 3 min. The HPLC method was validated for linearity, limits of\ndetection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in\nthe concentration ranges of 1ââ?¬â??44 Ã?¼g/mL for indacaterol maleate and 0.5ââ?¬â??20 Ã?¼g/mL for glycopyrronium bromide. Stability\ntests were done through exposure of the analyte solution for different stress conditions and the results indicate\nno interference of degradants with HPLC method.\nConclusions: The method was successfully applied for the quantitative analysis of indacaterol maleate and glycopyrronium\nbromide both individually and in a combined pharmaceutical inhaler capsules to support the quality control\nand to assure the therapeutic efficacy of the two drugs. The simple procedure involved in sample preparation and the\nshort run-time added the important property of high throughput to the method.
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