Comparison of Two Stability-Indicating Chromatographic Methods for the Determination of Mirabegron in Presence of Its Degradation Product

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• 作者：Ali M. Yehia ; Iman Sami ; Safa’a M. Riad ; Yasser S. El-Saharty
• 关键词：Mirabegron ; Stability indicating method ; Thin layer chromatography ; High performance liquid chromatography
• 刊名：Chromatographia
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：80
• 期：1
• 页码：99-107
• 全文大小：
• 刊物类别：Chemistry and Materials Science
• 刊物主题：Chromatography; Proteomics; Pharmacy; Laboratory Medicine;
• 出版者：Springer Berlin Heidelberg
• ISSN：1612-1112
• 卷排序：80

文摘

Mirabegron is a novel β₃-adrenoceptor agonist containing an amide group. It was subjected to stress conditions of acidic and alkaline hydrolyses. The hydrolytic degradation product was isolated and its structure was confirmed using mass and IR spectrometry. Two stability-indicating chromatographic methods have been proposed for the determination of mirabegron. TLC method was applied using silica gel as stationary phase and chloroform–methanol–ammonia (9.0:1.0:0.1 by volume) as the mobile phase, and chromatograms were scanned at 250 nm. Accurate determination of the drug was achieved over the concentration range of 2–12 μg per band. In addition, an isocratic HPLC method was developed on Agilent C18 column (150 mm × 4.5 mm I.D., particle size 5 µm) using ethanol-phosphate buffer pH 2.5 (30:70, by volume) as a mobile phase with flow rate of 1 mL min−1.The intact drug was detected at 250 nm with running time less than 5 min. Mirabegron was determined accurately in a concentration range of 1–25 µg mL−1. The proposed chromatographic methods were applied successfully for the assay of mirabegron in pharmaceutical dosage form and both methods were validated as per the International Conference on Harmonization guidelines and statistically compared with a reported gradient HPLC method.