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First Direct Isolation of Stable α-Form Crystals of Mirabegron, a Selective β3–Adrenoceptor Agonist

Vijayavitthal T. Mathad, Dattatray G. Deshmukh, Mukund N. Bangal, Anil C. Mali, Vijay J. Medhane

Abstract


An efficient and scalable method for the direct isolation of stable α-form crystals of mirabegron (1) is developed. The developed method negates transformation of metastable β-form crystals into α-form crystals thereby overcome the limitations of reported methods and avoids additional processing steps during its manufacture. The developed method directly provides stable α-form crystals of Mirabegron (1) with yield of around 84 % and purity of >99.77% by HPLC in a single step.


Keywords


β3-adrenoceptor agonist; Mirabegron; polymorphism; polymorphic transformation

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DOI: http://dx.doi.org/10.17344/acsi.2017.3293

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Copyright (c) 2017 Vijayavitthal T. Mathad, Dattatray G. Deshmukh, Mukund N. Bangal, Anil C. Mali, Vijay J. Medhane

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