Stable, Intended HPLC Method for the Determination of Mirabegron and its Impurity in Solid Dosage form

In the synthesis of active pharmaceutical ingredient and the development of pharmaceutical products, the impurities profiling plays a significant role. The control of impurities is essential for producing the quality, safe and efficient drug products for therapeutic use. Few works reported for the synthesis of potential impurities and further characterized to support the synthesis route and purity of the synthesized compound. Hence in present study, five impurities of mirabegron such as impurity 3, 4, 6, 8 and 9 were synthesized and structural characterization was carried using NMR, IR and mass spectral studies. Based on the results, it was confirmed that the route of synthesis established in the study was simple, convenient and economical and can be useful for the products of potential impurities of mirabegron. By characterizing each of these impurities, the regulatory need has been met. Additionally, the analytical method development and validation studies have utilized the generated impurity standards. This effort helped with the process development’s optimization stage and made it possible to identify the crucial parts of the process. The production method for mirabegron was carefully adjusted to eliminate or reduce the formation of impurities, which is helpful for the creation of safe pharmaceutical goods.

show abstract

Synthesis and Structural Characterization of Process Related Impurities of Mirabegron: A Beta-3 Adrenergic Agonist Drug

Gopa

Brahman

Mallu³

2022

Asian J. Chem.

View full text Add to dashboard Cite

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

Stable, Intended HPLC Method for the Determination of Mirabegron and its Impurity in Solid Dosage form

Cited by 1 publication

References 0 publications

Synthesis and Structural Characterization of Process Related Impurities of Mirabegron: A Beta-3 Adrenergic Agonist Drug

Synthesis and Structural Characterization of Process Related Impurities of Mirabegron: A Beta-3 Adrenergic Agonist Drug

Contact Info

Product

Resources

About